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Teva Sr Mgr PhV Safety Physician India, Karnataka, Bengaluru 267234318
Today
How you’ll spend your day
- Lead activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risks of assigned products throughout the product lifecycle including, as applicable, company sponsored studies, investigator sponsored studies, compassionate use, and disease monitoring programs.
- Lead and chair the cross-functional Product Safety Group. Be responsible for presenting decisions fromProduct Safety Group to senior safety governance committees as well as other forums attended by Teva's senior management.
- Accountable for medical evaluation/interpretation of aggregate safety data of assigned products andnon-assigned products, as required, including, but not limited to, signal detection and evaluation, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety review/assessments (such as Health Hazard Assessments, abbreviated safety evaluations, and Health Authority requests).
- Review of complex Health Hazard Assessments and Health Authorityrequests.
- Perform signal management activities such as signal validation QC, authoring of complex signalevaluations, and signal evaluation review. Act as medical reviewer to assess causality, consolidate safety information from different sources to determine whether a signal qualifies as a risk.
- Lead risk management activities for assigned products globally and contribute to the preparation ofRisk Management Plans (RMPs), REMS, design of additional risk minimization measures as well as management of these plans throughout the product's lifecycle. The Safety Physician is responsible to define the important identified risks, important potential risks, and the missing information.
- Represent PV in cross-functional Product Label Working Group. Lead evaluation and determination ofsafety related sections of the product label, both initial and throughout the product lifecycle; key member for safety related label negotiations with regulatory agencies as well as in the development and maintenance of CCSI.
- Provide PV support and safety contributions to Health Authority submissions andresponses.
JD to be contd.
- Collaborate with different functional stakeholders in Teva (Medical Affairs, Clinical Development, Quality, etc.) as well as outside Teva (KOLs, CROs, etc.) effectively representing PV position on any safety concerns as well as the overall safety profile of assigned products.
- Collaboratewithother cross-functionalteamstoensureexecutionofthesafetystrategy.
- Guide, provide support, and train, as applicable, safety physicians and safety scientists across safety surveillance activities such as medical review, signal detection, and risk evaluation activities.
- Representsafetyduringduediligenceof
Your experience and qualifications
- MBBS/MD degree or equivalent; clinical practice experience and/or epidemiological degree/training is an advantage.
- Strong knowledge of FDA and EMA regulations (GVP, GCP)
- Ability to work cross-functionally with an international team across multiple time zones.
- Fluent in English (speaking and writing)
- Min 4 to 5 years experience in Pharmacovigilance
- Experience in ICSR/medical review and signal detection
- Medical graduation registration in medical council (MCI or state council) is a must
Job-specific competencies
- Analytical Skills: Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc.), assess clinical importance, evaluate the benefit risk ratio, and potential strategic impact of the data and present the findings clearly in both written and oral communications.
- Results and Performance-Driven: Assumes personal ownership and accountability for business resultsandsolutions;consistentlydeliversresultsthatmeetorexceedexpectations; makesthepatientcentralto all thinking; keeps the focus on the value for patients (benefit/risk assessment). Holds himself/herself and others to the highest professional and ethical standards.
- Strong Interpersonal and People Skills: Ability to interact with individuals at a variety of functionallevels with both internal and external personnel, and the ability to perform cross-functionally.
Competencies to be contd.
- Social Intelligence Capabilities: Being socially intelligent and understanding others' behavior areimportant skillswhenworking inteams.TheSafety Physicianunderstands groupdynamics,identifyingand avoiding potential conflicts in a way that promotes everyone's interests and helps the team achieve its goals efficiently.
- CommunicationSkills:bothwrittenandoral:Communicationstyleshouldbediplomatic anddirect,butnot confrontational. He or she must be able to summarize information in an articulate, clear, tangible, manner both in written form and orally. Ability to influence, negotiate and communicate with both internal and external stakeholders.
- Problem-solving Skills: Creativity and practical experience to solve problems that arise in the
Reports To
Director,Pharmacovigilance
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