Job Title: Associate Director, Pharmacovigilance Safety (Fixed-term contract)
Location: Bucharest, Romania
Company: Teva Pharmaceuticals
Job ID: 57908
Date: Nov 15, 2024
About Teva Pharmaceuticals
Teva is a global leader in pharmaceuticals and the world's largest producer of generic medicines. We are committed to improving health and increasing access to quality health solutions worldwide. With colleagues in over 80 countries, we deliver the world’s largest medicine cabinet to 200 million people every day. Teva is focused on delivering patient-centric solutions and significantly growing in both our generic and specialty medicines sectors. Through continuous investment in research and development, we aim to improve health and empower people to live healthier lives.
The Opportunity
As an Associate Director, Pharmacovigilance Safety Physician, you will play a critical role in determining the safety profile, monitoring, and mitigating risks for assigned products throughout their lifecycle. You will also be responsible for providing comprehensive safety information to patients, prescribers, and regulators.
Key Responsibilities
Safety Profile Management:
Be accountable for the medical evaluation and interpretation of safety data for both assigned and non-assigned products.
Perform signal detection, dose escalation evaluations, and preparation of regulatory safety reports (e.g., PSUR, PADER, DSUR).
Review complex Health Hazard Assessments and Health Authority requests.
Signal Management:
Conduct signal validation, author complex signal evaluations, and manage signal evaluation reviews.
Act as a medical reviewer to assess causality and consolidate safety data to determine if a signal qualifies as a risk.
Risk Management:
Support the development and implementation of Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and additional risk minimization strategies.
Define important identified risks, important potential risks, and missing information for assigned products.
Cross-Functional Collaboration:
Represent Pharmacovigilance (PV) in the Product Label Working Group, ensuring safety-related sections of product labels are evaluated and negotiated with regulatory agencies.
Collaborate with both internal (e.g., Medical Affairs, Clinical Development, Quality) and external stakeholders (e.g., KOLs, CROs) to effectively represent PV on safety concerns and the overall safety profile of products.
Health Authority Submissions:
Provide PV support for Health Authority submissions and responses.
Represent PV during due diligence for potential new products.
Qualifications and Experience
Medical Doctor degree (MD) or equivalent.
Clinical practice experience and/or epidemiological training.
A minimum of 3 years of experience in pharmacovigilance and drug safety, specifically as a safety physician.
Proven ability to handle safety surveillance tasks and lead safety committee meetings.
Ability to serve as a subject matter expert in pharmacovigilance.
Strong communication skills with the ability to collaborate across departments and influence others without direct authority.
Ability to work cross-functionally within a matrix team, across multiple time zones.
Fluency in English (oral and written).
Reports To
Sr Dir, Pharmacovigilance
Teva’s Equal Employment Opportunity Commitment
Teva is committed to equal opportunity in employment and a diverse and inclusive workplace for all. We provide equal opportunities regardless of age, race, creed, religion, sex, disability, pregnancy, sexual orientation, gender identity, ancestry, veteran status, or any other legally protected status. If you require accommodations during the recruitment process, please let us know.
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