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Sr Mgr PhV Safety Physician
4-5 years
Bangalore / Bengaluru
1 vacancy
Sr Mgr PhV Safety Physician
Watson Pharama
posted 1mon ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
- 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 from Product Safety Group to senior safety governance committees as well as other forums attended by Tevas senior management.
- Accountable for medical evaluation/interpretation of aggregate safety data of assigned products and non-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 Authority requests.
- Perform signal management activities such as signal validation QC, authoring of complex signal evaluations, 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 of Risk Management Plans (RMPs), REMS, design of additional risk minimization measures as well as management of these plans throughout the products 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 of safety 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 and responses.
- 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.
- Collaborate with other cross-functional teams to ensure execution of the safety strategy.
- 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.
- Represent safety during due diligence of products
- 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
Employment Type: Full Time, Permanent
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based on 8 employees
Strict timing
Monday to Friday
Within city
Day Shift
Watson Pharama Benefits
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