Safety Physician Director Pharmacovigilance
5 days ago
Job Summary
Teva Pharmaceuticals is seeking a highly skilled Safety Physician Director Pharmacovigilance to join our Medical Scientific Unit (MSU). As a key member of our team, you will play a critical role in ensuring the safety of our innovative products in pre- and post-marketing environments.
Key Responsibilities- Lead Safety Activities
Develop and implement strategies to determine the safety profile and characterize, monitor, and mitigate risks of assigned products during clinical development and/or post-marketing.
Collaborate with Cross-Functional TeamsWork closely with R&D and other cross-functional teams to ensure the execution of the safety strategy and contribute to clinical documents, such as study protocols, informed consent forms, and clinical study reports.
Chair Product Safety GroupLead and chair the cross-functional Product Safety Group, presenting decisions to senior safety governance committees and other forums attended by Teva's senior management.
Medical Review and AssessmentPerform medical review and assessment of Individual Case Safety Reports (ICSRs) for assigned products from clinical trials.
Signal Detection and EvaluationAccountable for medical evaluation/interpretation of aggregate safety data of assigned products, including signal detection and evaluation, dose escalation evaluations, and regulatory safety reports.
Risk ManagementLead risk management activities for assigned products globally, contributing to the preparation of Risk Management Plans (RMPs), REMS, and design of additional risk minimization measures.
Product Label EvaluationRepresent PV in cross-functional Product Label Working Group, leading evaluation and determination of safety-related sections of the product label, and key member for safety-related label negotiations with regulatory agencies.
Health Authority SubmissionsProvide PV support and safety contributions to Health Authority submissions (MAA/NDA/BLA submissions) and responses, supporting global launch activities for assigned products.
Collaboration and TrainingCollaborate with different functional stakeholders in Teva and outside Teva, effectively representing PV position on any safety concerns, and guide, provide support, and train safety physicians and safety scientists across safety surveillance activities.
Requirements- MD Degree or Equivalent
- General Practitioner License
- 3+ Years of Experience in Pharmacovigilance and Drug Safety
- Strong Knowledge of FDA and EMA Regulations
- Experience with NDA/BLA Submissions
- Ability to Work Cross-Functionally
- Excellent Communication Skills in English
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