Social Media RSS Feed en PhD Position (Doctoral Researcher) (f/m/x, 65%) <p><strong>What we offer</strong><br /> You will contribute to the project “The Rise of Populist Parties in Europe: The Dark Side of Globalisation and Technological Change?” and be part of a dynamic team of economists regularly publishing its work in renowned international journals. You will find a well-equipped research infrastructure and an open-minded and cooperative working environment. The Halle Institute for Economic Research is closely linked with the national and international scientific community and offers excellent opportunities to gain academic qualifications. In particular, you will be given the opportunity to obtain a doctoral degree.</p> <p><strong>Your profile/Your motivation</strong><br /> You hold a high-quality master degree in economics or related fields and have a solid background in microeconometrics and ideally some experience with empirical work. You have a strong interest in labour, regional, and international economics, you are willing to work on interdisciplinary research questions, possess the skills to present complex questions in English, and work independently and well organised. You are open to get in touch with the national and international scientific community and to cooperate with other IWH researchers. Participation in the <a href="">IWH Doctoral Programme in Economics (IWH-DPE)</a> and the <a href="">Central-German Doctoral Program in Economics (CGDE)</a>, which IWH organises jointly with neighboring universities, is obligatory.</p> <p><strong>Further information</strong><br /> The IWH considers itself a family-friendly employer that guarantees equal opportunities for women and men and hereby strongly encourages women to apply for this position.<br /> Remuneration and benefits correspond to the German public sector salary scheme (up to pay group 13 Tarifvertrag der Länder, TV-L).<br /> Candidates with disabilities and their peers are encouraged to indicate a severe disability in their application.</p> <p><strong>Application procedure</strong><br /> Your resume and CV with evidence of all qualifications should be addressed with indication 2019-07 by December 1st, 2019 electronically in a single pdf file to <a href=""></a>. For administrative inquiries, please contact Ms. Kristin Hüttner (<a href=""></a>, Tel +49 345 7753 831).</p> Wed, 11/13/2019 - 03:30 1412781 1412781 Ph.D. Supplementary Courses <p>Over the years, Ph.D students, staff members of national and international institutions, think tanks and financial companies have updated and deepened their economic research knowledge in one area of expertise by attending a course.</p> <p>Written exams are offered for all courses, with 3 credit points for a one-week course and 6 credit points for a two-week course.</p> <p>PhD candidates can apply for participation in one or several courses of the program and are entitled to substantially reduced course fees. They can also apply for low-price accommodation at the Kiel Institute´s guesthouse.</p> <p><strong>New:</strong>  Candidates can attend the Modular ASP program and acquire the Advanced Studies Certificate (which is a particularly ). The ASP Modular Option which is designed for Ph.D candidates, staff members of national and international institutions, think tanks or private companies who seek to take full advantage of the Advanced Studies Program Certificate, without taking an extended leave of absence. The Advanced Studies Certificate is a particularly valuable additional qualification for professional careers at international organizations and policy institutions. Participants can take courses at their own pace and have up to 34 months to complete all of the necessary courses to obtain the ASP Certificate. Accordingly, participants broaden their skills by learning from leading professors and joining a close-knit network of researchers and practitioners, but do so at the pace that best suits their individual needs.</p> <p>Forthcoming Courses: <strong>                                                                    </strong></p> <p><strong>14 - 18 Oct 2019:<br /> Economic Growth - David Hémous (Zürich)</strong></p> <p><strong>11 - 15 Nov 2019:<br /> Forecasting Methods - Jens Boysen-Hogrefe (Kiel)</strong></p> <p><strong>09 - 13 Dec 2019<br /> Applied Microeconometric Methods - Sourafel Girma (Nottingham)</strong></p> <p><strong>17 - 19 Dec 2019<br /> Topics in International Trade - Arnaud Costinot (MIT)</strong></p> <p><strong>24- 26 Feb. 2020<br /> Topics in International Macroeconomics and Finance - Matteo Maggiori (Harvard)</strong></p> <p><strong>20- 24 Apr. 2020<br /> Topics in Development Economics - Christopher Udry (Northwestern)</strong></p> <p><strong>4- 8 May 2020<br /> Trade Policy Analysis with Gravity Models - Yoto Yotov</strong></p> <p> </p> <p>For outlines and application forms visit our webpage. </p> Wed, 11/13/2019 - 03:30 99195 99195 University Assistant without doctorate <p>You will be supported by me to freely and independently perform research in the field of microeconomic theory. This includes game theory (the theory of strategic thinking) and related areas such as mechanism design or decision theory. Your research can be either methodological or applied to social or economic issues. Your research may also have empirical or experimental elements. Cooperation with researchers outside the Department of Economics (also internationally) is possible and welcome.</p> <p>Your goal should be a research career. Our common goal would then be for you to develop yourself scientifically with my support, in such a way that at the end of your doctorate you will be successful on the international job market for researchers in economics.</p> <p>Publications and topics of my previous doctoral students can be found at <a href=""></a>. You can find my own research at <a href=""></a>. Letters of Recommendation can be sent together with your application. If you have any further questions, please contact me at <a href=""></a>.</p> <ul> </ul> Wed, 11/13/2019 - 00:00 1413699 1413699 PhD scholarship in Finance <p>ABOUT THE SCHOOL: IESE Business School is today one of the world’s leading business schools, with campuses in Barcelona, Madrid, Munich, New York, and São Paulo. IESE offers Master of Business Administration (MBA), Executive MBA and Executive Education programs that are regularly ranked among the top 10 in the world.</p> <p> </p> <p>ABOUT THE DEPARTMENT: IESE’s Finance department comprises 13 full-time professors who work closely together with the IESE doctoral students across a very broad range of topics, such as corporate finance, asset pricing, banking and financial intermediation, FinTech, real estate finance, corporate governance, and mergers and acquisitions.</p> <p> </p> <p>ABOUT THE PROGRAM: IESE’s PhD/Doctorate program is based on the traditional U.S. model with fundamental finance coursework before enrolment into the PhD phase. The doctoral program provides full financial funding during the entire program, that is, a stipend of 16.695€/yearly and a tuition fee waiver. Moreover, there is an additional budget for travel expenses to attend and present at research conferences. </p> <p> </p> <p>QUALIFICATIONS: Required is a bachelor or master degree with a strong academic record and the motivation to produce top-level research. </p> <p> </p> <p>APPLICATIONS/FURTHER INFORMATION: Applications are now being accepted for the September 2020 intake. If you are interested in the position, please send an email including a cover letter, your CV, and academic transcripts to:</p> Tue, 11/12/2019 - 23:04 1413774 1413774 ECONOMIST specialised in the Western Balkans, macroeconomics and/or monetary policy and finance <p>The Vienna Institute for International Economic Studies (wiiw) is one of the principal centres for economic research on Central, East and Southeast Europe (CESEE) with more than 45 years of experience. We have expanded our work on European integration issues more generally encompassing the CESEE EU member states, but also developments in Wider Europe and its neighbourhood. We also cover a wide variety of issues in International Economics. Our thematic research covers macroeconomic analysis, international economics, labour markets, regional analysis, industrial organisation. Research projects are commissioned by national and international clients and emerge from applications to research funding agencies. We coordinate and are integrated in a large number of international research networks. For more details please visit our website: <strong></strong></p> <p>We are looking for an<strong> ECONOMIST</strong> specialised in the <strong>Western Balkans, macroeconomics and/or monetary policy and finance</strong></p> <p><strong>Major tasks:</strong></p> <ul> <li>Research on the economies of the Western Balkans and country monitoring</li> <li>Widen our expertise on macroeconomics, monetary policy and finance</li> <li>Acquisition and execution of research projects</li> </ul> <p><strong>Requirements:</strong></p> <ul> <li>MA or PhD in Economics</li> <li>Research experience in macro-economics and/or monetary policy and finance</li> <li>Interest in applied research</li> <li>Good quantitative and econometric skills</li> <li>Knowledge of both conventional and heterodox economic analyses</li> <li>Excellent English (written and oral); knowledge of a Southeast European language as well as German is an advantage</li> <li>Very good (proposal) writing and presentation skills</li> <li>Flexibility as well as ability to work in teams</li> </ul> <p>The position is limited to one year in the first instance; can be extended following a satisfactory probationary period</p> <p>Start: as soon as possible – ideally by January 2020</p> <p>We pay salaries comparable to universities. Remuneration for the position will be € 39,000 gross annual income or above, depending on qualification. Women are encouraged to apply.</p> <p>Please send your application (with cover letter, CV and copies of certificates) to<strong> <em></em></strong></p> Tue, 11/12/2019 - 17:17 1413709 1413709 Senior Partnering Executive at Atomwise <p> </p> <p> </p> <p> </p> <p>You will</p> <ul> <li>Grow a robust network of relationships with academic institutions and researchers</li> <li>Negotiate diverse types of contracts and business models</li> <li>Build trust and strong collaborations</li> <li>Recognize opportunities in early stage academic research and identify potential paths to commercialization</li> <li>Educate potential partners about our technology and understand how it might be applied to their specific drug development program</li> <li>Present at conferences and meetings</li> <li>Create and develop research plans with our chemistry team</li> </ul> <p>Required</p> <ul> <li>7+ years experience in academic tech transfer or in external innovation for a pharmaceutical or biotechnology company</li> <li>Experience managing a team</li> <li>Minimum of a bachelor’s degree in biology, chemistry or a related field</li> <li>Highly motivated and detail-oriented</li> <li>Extremely organized with a high degree of attention to detail</li> <li>Energetic and focused with the ability to prioritize</li> </ul> <p>Preferred</p> <ul> <li>Experience reviewing and editing contracts</li> <li>Masters or Ph.D. in a scientific discipline, MBA, MD or JD</li> <li>Knowledge of small molecule drug discovery and development</li> <li>A network of existing relationships in pharma and biotech</li> </ul> <p>When applying, please provide</p> <ul> <li>A paragraph stating how Atomwise can help you to achieve your career goals</li> <li>A resume</li> </ul> <p>Compensation & Benefits</p> <ul> <li>Stock compensation plan – you’ll be an Atomwise co-owner</li> <li>Platinum health, dental, and vision benefits</li> <li>401k with 4% match</li> <li>Great colleagues</li> </ul> <p> </p> <p> </p> <h3> </h3> Tue, 11/12/2019 - 17:03 1412106 1412106 Post-Doctoral Scholar <h2>Post-Doctoral Scholar - Chemistry & Chemical Biology</h2> <p>Job #JPF00885</p> <h3>Recruitment Period</h3> <h3>Description</h3> <p>Multiple postdoctoral positions are available in Computational Chemistry/Physics/Data Science. Professors Christine Isborn, Liang Shi, David Strubbe, Aurora Pribram-Jones, and Harish Bhat are looking for post-docs with strong expertise in data science, electronic structure, excited states, electron dynamics, condensed-phase dynamics, and/or spectroscopy. Specific projects of interest are listed below.</p> <ol> <li> <p>Modeling linear and nonlinear optical spectroscopy of solution phase systems using dynamic approaches (correlation functions/cumulant expansion). This position will involve developing and testing new spectroscopic methods, running molecular dynamics simulations, and performing TDDFT excited state calculations. (Christine Isborn and Liang Shi groups)</p> </li> <li> <p>Modeling light-induced degradation in organic photovoltaics. This project involves the use of TDDFT and GW/Bethe-Salpeter approaches to calculate atomic motions after light absorption in photovoltaic materials to investigate how light can form defects and cause degradation of electronic and optical properties. (David Strubbe group)</p> </li> <li> <p>Using data science methods to model and gain insight into excited states and TDDFT electron dynamics. In particular, this project will use deep learning methods such as recurrent neural networks to predict electron dynamics and will apply interpretability methods, such as equation discovery and sensitivity analysis, to also yield interpretable approximations of potentials. (Christine Isborn and Harish Bhat groups)</p> </li> <li> <p>Using data science methods such as memory-constrained auto-encoders to determine an optimal subspace (projection operator) for nonadiabatic dynamics. (Harish Bhat group)</p> </li> <li> <p>Analysis and development of finite-temperature strictly correlated electron-referenced density functional theory, via formal derivations, numerical demonstrations, and analytical studies. (Pribram-Jones group)</p> </li> <li> <p>Using real-time electronic structure methods to investigate the importance of approximate and exact exchange-correlation in laser-molecule interactions. (Pribram-Jones group)</p> </li> </ol> <p>The applicant should indicate the research areas of interest within the Cover Letter.</p> <p>Duties will include: running calculations using standard and non-standard ab initio and QM/MM codes, modifying and developing code as needed, writing scripts to analyze data, writing journal articles on developed methods and results of calculations, communicating effectively with colleagues, mentoring undergraduate and graduate students, and attending conferences to present results.</p> <p>The minimum qualifications required for this position is a recent Ph.D. in theoretical chemistry or physics (or a closely related field); for projects with Prof. Bhat, a Ph.D. in applied math, computer science, statistics (or a closely related field) is required.</p> <p>Interested applicants are required to submit 1) a cover letter, 2) a curriculum vitae and 3) a statement of research interests and 4) a contribution to Diversity, Equity and Inclusion Statement.</p> <p>*The contributions to diversity, equity and inclusion statement should describe your past experience, activities and future plans to advance diversity, equity and inclusion, in alignment with UC Merced’s mission to reflect the diversity of California and to meet the educational needs and interests of its diverse population. Some candidates may not have substantial past activities. If that is the case, we recommend focusing on future plans in your statement. Guidance on what to include in a diversity statement may be found here.</p> <p>Review of applications will begin on 10/9/2019; this search will be open until the position is filled with a final closing date of 9/14/2020.</p> <p>Salary is based on the University of California Academic Salary Scales. This is a full-time, one-year appointment with the possibility of renewal based on availability of funding, ongoing operational needs and satisfactory performance.</p> <p>The University of California, Merced is an affirmative action/equal opportunity employer with a strong institutional commitment to the achievement of diversity among its faculty, staff, and students. The University is supportive of dual career couples.</p> <p>The University of California, Merced, is the newest of the University of California system’s 10 campuses. With 8,500 undergraduate and graduate students (, UC Merced is committed to interdisciplinary excellence in research and teaching as well as to diversity, equity and inclusion. Ranked as one of the best public universities in the nation by U.S. News and World Report, UC Merced provides outstanding educational opportunities to highly qualified students from the heart of California, the nation, and abroad. The campus has special connections to nearby Yosemite National Park; is on the cutting edge of sustainability in construction and design; and supports the economic development of Central California. The Merced 2020 Project doubled the physical capacity of the campus, and enhanced academic distinction, student success, and research excellence (</p> <p> </p> Tue, 11/12/2019 - 16:59 1403701 1403701 BCU Manager, IT Business Analysts <p><strong>Req #:</strong> JR - 009380 <strong>Job Category:</strong>Baxter Credit Union <strong>Date Posted:</strong> 10/8/2019 5:54:58 PMBaxter International</p> <p>Around the world, our employees are united by our mission to save and sustain lives. Together, we create a culture that encourages colleagues to pursue rewarding careers -- where everyone has the opportunity to do meaningful work as a part of a team they respect, in an environment that values each person’s contributions. We’re happy you’re interested in continuing your career journey with Baxter.</p> <p>BCU is looking for a self-driven individual with exceptionally strong communication and management skills to lead and work alongside a team of highly independent and mature Business Analysts.</p> <p>This position reports to the Director of the PMO, and will lead fulltime business analysts as well as contractors in their execution of projects/initiatives that fall under the IT-PM. The IT BA Manager plays a leadership role in business problem solving and is highly capable of defining the business problems/conditions, assessing business capabilities/deficiencies, driving innovative ideas and solutions, and recommending actionable next steps for business executives, project teams, or workgroups to take.</p> <p>This roles requires an individual to have years of deep practical work experience in performing and managing others that perform business analysis in a variety of complex situations. The individual in this role has great expertise with regards to what techniques to use and what influences the usage of the various techniques for the tasks. He or she works autonomously to plan, supervise and lead the work of other BAs on projects and work efforts.</p> <p>This individual will manage both fulltime employees & contractors and execute projects/initiatives that fall under the IT Program Management Office. In this role the individual will:</p> <ul> <li>Be responsible to guide, manage, and direct the activities of business analysts in the development of requirements specifications for application enhancements and upgrades. Participating in resourcing, budgeting and quality improvement activities for the organization.</li> <li>Build and encourage growth of the Business Analysis team; is responsible for providing guidance, direction, feedback and coaching to direct reports as well as assigned project resources to ensure team effectiveness</li> <li>Guide business analyst teams and cross-competency teams completing tasks related to business solution planning, business case development as well as documenting and managing customer requirements throughout the development lifecycle. This includes requirements elicitation, analysis, definition, review, and approval, business process analysis; requirements change management, user story creation, and business process modeling, logical system and data design and high level estimating.</li> <li>Work collaboratively with business representatives, project management and varied information systems teams to develop and implement the specific technology and architecture necessary to deliver business solutions</li> <li>Responsible for hiring, training, and supervising staff</li> <li>Participate in organizational activities related to assigning resources, managing and mentoring team members through strategic deployment, development and performance management</li> <li>Analyze and organize business analyst operations and procedures as well as serve as an advocate for process improvement initiatives with in the team and broader business analysis center of excellence.</li> <li>Partner with other resource coordinators to source and share resources for effective resource utilization.</li> </ul> <p><b>Required Qualifications</b></p> <p>Minimum 10 years’ experience working in software development life cycle (SDLC) and process engineering environment. Expertise managing customer requirements or demands effectively, meeting deliverable dates, leading work group(s), driving process improvements and directing customer contact.</p> <p>Minimum of 5 years’ experience managing and instilling best practices that:</p> <ul> <li>Support the goals and objectives of the enterprise and/or operational area</li> <li>Develop Use Cases and Test Scenarios; develop and document processes and work flows to enhance efficiencies and improve support and performance</li> <li>Elicit, gather, document and clearly communicate requirements, as well as analysis, translation and reconciling requirements</li> <li>Build trusted and long-lasting business relationships through assignments and association, consistently seek ways to enhance delivery and to better understand, identify, and work through issues across efforts</li> <li>Enable the team to conduct cost/benefit analysis of process and/or technology initiatives</li> </ul> <p><b>Preferred Qualifications</b></p> <ul> <li>Organizational change management knowledge a plus</li> <li>Agile methodology</li> <li>Technical and development background a plus</li> <li>Experience managing remote employees highly-desirable</li> </ul> <p><b>Education</b></p> <ul> <li>Certification of Capability in Business Analysis (CCBA) or Certified Business Analysis Professional is preferred</li> <li>MS or MBA in Computer Science, Information Systems or equivalent preferred.</li> </ul> <p><b>Equal Employment Opportunity</b></p> <p>Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.                                                                                </p> <p><b>Reasonable Accommodations</b></p> <p>Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.</p> Tue, 11/12/2019 - 16:58 1408058 1408058 Power Electronics Systems Engineer <p style="margin:0cm 0cm 8pt"><span style="font-size:16px;"><span style="font-family:Arial,Helvetica,sans-serif;">We’re in a period of unprecedented innovation in the automotive industry as we move away from conventional powertrains towards hybrid and eventually fully electric vehicles. We want you to join us on this journey. With your knowledge of power electronics and hybrid systems, you can join the team designing the next generation of McLaren supercars and innovating to incorporate more hybrid and electric drive technology.</span></span></p> <p style="margin:0cm 0cm 8pt"> </p> <p style="margin:0cm 0cm 8pt"><span style="font-size:16px;"><span style="font-family:Arial,Helvetica,sans-serif;">You’ll be designing and delivering power electronic components like motor control units, inverters, converters, and chargers, from start to finish. As part of this development cycle you’ll be generating and managing the requirements, carrying out design and design releases, simulation, and supplier management. You will also be contributing to technology roadmaps to ensure our long-term focus is achieved.  </span></span></p> <p style="margin:0cm 0cm 8pt"> </p> <p style="margin:0cm 0cm 8pt"><span style="font-size:16px;"><span style="font-family:Arial,Helvetica,sans-serif;">Collaboration is key in this role. You’ll need to work with power electronics suppliers, internal concept teams, and external research organisations to deliver design solutions that meet the programme targets. The team is split between two sites, and you’ll be based in our new, state-of-the-art facility in Sheffield, and working closely with the team in our headquarters in Woking, Surrey.</span></span></p> <p style="margin:0cm 0cm 8pt"> </p> <p style="margin:0cm 0cm 8pt"><span style="font-size:16px;"><span style="font-family:Arial,Helvetica,sans-serif;">Building on the success of the McLaren P1, we’re committed to increased hybridisation in our Track 25 business plan, which sets out our goal for all our new powertrains to be 100% hybrid by 2025. Due to this ambition it’s a highly demanding programme to be a part of, but one that is sure to be rewarding. The team is around 30 strong currently and is planned to grow to around 70, meaning more opportunity for you: opportunity for progression; to take on new challenges; and learn novel areas of technology as you help McLaren to innovate.</span></span></p> <p style="margin:0cm 0cm 8pt"> </p> <p style="margin:0cm 0cm 8pt"><span style="font-size:16px;"><span style="font-family:Arial,Helvetica,sans-serif;">We’re looking for you to have a good level of experience with hybrid electrical systems design, and good CATIA v5 skills including GD&T application. It’ll also be useful for you to have good mechanical packaging and design release experience. You’ll need to have a good understanding of HV switchgear, electrical/ electronics hardware like circuit layouts and schematics. Knowledge of DC/DC converters and chargers is also beneficial. If you have a passion for the industry and to develop in this field, this is the time to join us.</span></span></p> <p style="margin:0cm 0cm 8pt"> </p> <p style="margin:0cm 0cm 8pt"><span style="font-size:16px;"><span style="font-family:Arial,Helvetica,sans-serif;">Apply now or send me your CV: <a href=""></a></span></span></p> Tue, 11/12/2019 - 16:55 1399060 1399060 Pharmacovigilance Specialist <p> </p> <p><b>Are you looking for a career that matters?</b></p> <p>We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.</p> <p><b>It’s impossible to list everything you’ll do here because every day is different. But a few things are clear:</b></p> <ul> <li>Implement and ensure compliance to the Baxter Pharmacovigilance (PV) system for medicinal products and biologics in Malaysia/Indonesia, in compliance with the local national regulations/standards; Global PV legislations/ standards; and Baxter policies/ procedures at a local, regional and global level</li> <li>Act as a local Qualified Person Responsible for Pharmacovigilance in Malaysia/Indonesia (as per applicable local legislation)</li> <li>Perform appropriate Safety Risk Management activities in Malaysia/Indonesia in order to assure oversight of medicinal product safety and to ensure that appropriate action be taken when necessary, e.g., implementation of risk management activities</li> <li>Maintain a thorough understanding of and comply with the Baxter Pharmacovigilance Quality System and Policies</li> <li>Ensure all safety information at a local level is captured in the Global Pharmacovigilance Safety database and submitted to regulatory authorities as per regulatory requirements, within reporting timelines</li> <li>Ensure appropriate liaison with country Medical Affairs, Regulatory Affairs, Clinical, Quality, Business Units, Legal, etc., to ensure Pharmacovigilance input into country strategic planning for products Throughout their lifecycle</li> <li>Continually and proactively improve and develop the PV system and department to meet the needs and requirements of Baxter, and Pharmacovigilance regulations and standards</li> </ul> <p><b>Main Accountabilities</b><b>Local QPPV Role for Malaysia and Indonesia</b></p> <ul> <li>In the capacity of Local QPPV (Local Qualified Person Responsible for Pharmacovigilance), have an oversight of all pharmacovigilance activities as per applicable local legislation</li> </ul> <p><b>Safety Risk Management Activities</b></p> <ul> <li>Identify the local regulatory requirements for RMP (Risk Management Plan) submissions, communicate the requirements to the Global team and provide local inputs as required. Implementing risk minimization measures locally as appropriate</li> <li>Identify, escalate and communicate all relevant local critical safety issues/signals</li> <li>Perform surveillance activities for any new potential safety information (e.g. similar AEs reported in a cluster of reports or multiple cases for one batch received in a short time frame) and escalate as per procedures</li> <li>Maintain an overview of the safety profiles of medicinal products, of any emerging safety concern or other information relating to evaluation of the benefit-risk of medicinal products for which Baxter holds a marketing authorization in Malaysia and Indonesia</li> </ul> <p><b>PV Quality Systems</b></p> <ul> <li>Maintain expert knowledge and awareness of local pharmacovigilance regulations and implement as appropriate</li> <li>Ensure adequate understanding of audit and inspection preparation and readiness</li> <li>Ensure understanding of the CAPA (Corrective and Preventive Actions) process. Responsible for performing CAPA activities per identified roles</li> <li>Ensure compliance with procedure for document management retention and archiving</li> <li>Understand and implement the document change management process and act as SME (Subject Matter Expert) for local procedures</li> <li>Ensure all training requirements for the role are met</li> <li>Identify appropriate stake holders and ensure they are trained on PV reporting requirements/procedures</li> <li>Build alignment and collaboration with local Regulatory Affairs, Medical Affairs, clinical Operations, Quality Assurance, and Business Unit teams</li> <li>Communicate effectively all relevant safety information and compliance concerns with the AP Regional PV</li> <li>Ensure adherence and appropriate implementation of the BCP (Business continuity Plan)</li> <li>With regards to third party agreements</li> <li>Perform due diligence and ensure the appropriate PV/safety requirements are incorporated into the agreements</li> <li>Perform regular review of the agreements to ensure safety requirements are aligned to the current regulatory requirements and perform reconciliation of data between the third party and Baxter</li> <li>Have responsibility for the oversight of Safety signals for agreements where the Third party is the MAH (Market Authorization Holder)</li> </ul> <p><b>Baxter PV Signal Management</b></p> <ul> <li>At adverse event case receipt, analyze for safety information that requires immediate forwarding to Drug Safety Physician</li> <li>Collection of as much AE case information as possible</li> <li>Escalation of requests, received directly local PV contact or indirectly (by country RA/Country QA) from Regulatory Authorities relating to product safety, efficacy and quality</li> </ul> <p><b>Case Intake</b></p> <ul> <li>Manage the receipt and capture process for adverse event (AE) and other safety information report collection in the Pharmacovigilance safety database</li> <li>Various sources of AE include but are not limited to; spontaneously reported cases from patients, HCP, nurses, Baxter employees (Including AEs associated with product complaints and AEs associated with medical queries). Social media reports, partner companies and regulatory authorities; and solicited cases from patient support programs, market research programs, clinical studies and call centers</li> <li>Asses the need for utilizing appropriate forms and questionnaires, complete appropriate forms and capture the information in the Pharmacovigilance safety database</li> <li>Perform the initial assessment on the case validity, check for core case elements. Perform duplicate checks and request for case deletion as required</li> <li>Perform a seriousness assessment and assess expectedness against the local label</li> <li>Perform translation of source documents and local quality check of translation as required. Ensure all source documents are captured in the Pharmacovigilance safety database</li> <li>Determine the requirements for follow up information and manage the process for collection and handling queries from the Global team</li> <li>Re-assess the follow up information in the context of case validity, seriousness and expectedness; capture all follow up information and source documents in the Pharmacovigilance safety database</li> <li>Perform ongoing tracking and local quality check and AE cases for follow up and submission requirements</li> <li>Manage patient identified batch review requests as required</li> <li>Perform reconciliation actives for AE cases as required</li> </ul> <p><b>Regulatory Submissions</b></p> <ul> <li>Maintain expert knowledge of the regulatory reporting requirements and ensure the reporting rules in the system are aligned to the local reporting requirements</li> <li>Manage the process for expedited submission of AEs to local authorities with translation of documents as required. Track submissions in the Pharmacovigilance safety database and archive all submission records</li> <li>Respond to submission related queries from the local regulatory authorities and archive all regulatory related correspondence</li> </ul> <p><b>Other Responsibilities</b></p> <ul> <li>Provide the appropriate local inputs for the PSMF (Pharmacovigilance System Master File) sections</li> <li>Understand any specific local regulatory report requirements (e.g., AE line listing), request the required information from the Global team and submit the reports to authorities as per regulatory requirements</li> <li>Provide back up support to Local PV SEA cluster activities, as needed</li> <li>Ensure all obligations are met as per safety data exchange agreements (SDEA) with business partners</li> <li>Escalation of requests, received directly by local PV contact or indirectly (by Country RA /Country QA) from Regulatory Authorities relating to product safety, efficacy and quality must be disseminated to Pharmacovigilance Officer In charge, Director, Asia Pacific (APAC) Regional PV and other stakeholders as per Baxter procedural requirements</li> <li>Other tasks as assigned by Regional APAC Pharmacovigilance</li> </ul> <p><b>Educational Background/Experience</b></p> <ul> <li>Bachelor’s degree, preferable to bachelor’s degree in pharmacy, nursing, or medical science or an equivalent degree in a scientific field</li> <li>At least 2 years experience in related pharmacovigilance role within the pharmaceutical industry</li> </ul> <p> <b>Qualifications/Competencies</b></p> <ul> <li>Expert knowledge of the PV relevant local regulatory framework, and sound knowledge of international PV relevant regulations and standards, e.g., GVP</li> <li>Working knowledge of the clinical drug development process and GCP</li> <li>Excellent analytical & problem solving skills</li> <li>Excellent oral & written communication & interpersonal skills</li> <li>Operates effectively in a team environment</li> <li>Ability to work under strict deadline and changing priorities with some supervision</li> <li>Attention to detail</li> </ul> <p><b>Equal Employment Opportunity</b></p> <p>Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.                                                                                </p> <p><b>Reasonable Accommodations</b></p> <p>Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information.</p> Tue, 11/12/2019 - 16:53 1405828 1405828