Job Description
I am partnered with a pioneering, global biopharma who has led the industry in remarkable scientific breakthroughs to enhance people's lives. They are currently looking for a Medical Director, Drug Safety to add to their Immunology group.
Internal & External Safety Expert
- Provide pharmacovigilance (PV) and risk management expertise to both internal and external stakeholders.
- Act as the safety expert for products.
- Stay informed about the product, its environment, and recent literature.
- Maintain PV expertise and a thorough understanding of international safety regulations and guidelines.
- Lead cross-functional Safety Management Teams (SMTs).
- Communicate and represent PV analyses and positions within project/product teams, safety governance, and benefit-risk governance activities and committees (e.g., Safety Management Committee, Benefit-Risk Assessment Committee), with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations.
- Offer strategic and proactive safety input into development plans.
- Support due diligence activities and pharmacovigilance agreements.
Signal Detection & Assessment
- Responsible for signal detection and analysis.
- Collaborate with the Center of Excellence for Signal Detection, Data Mining, and Safety Epidemiology group.
- Identify and implement proactive safety analysis strategies to further define the safety profile.
- Lead aggregate safety data review activities and coordinate safety surveillance activities.
Risk Assessment & Risk Management & Benefit-Risk Assessment
- Provide proactive risk assessment.
- Co-lead benefit-risk assessment with other relevant functions.
- Develop risk management strategies and plans and monitor their effectiveness.
- Collaborate with the Center of Excellence for Risk Management and Epidemiology/Benefit-Risk groups.
Submission Activities
- Represent the safety position in cross-functional submission teams.
- Ensure the generation, consistency, and quality of safety sections in submission documents.
- Write responses or contributions to health authorities questions.
- Support the preparation and conduct of Advisory Committee meetings.
Report Writing
- Document, contribute to, coordinate, review, and/or validate periodic reports, such as RMP updates, IND Annual Reports, Annual Safety Reports/Development Safety Update Reports, and Periodic Safety Update Reports.
- Serve as the medical safety expert to the GPV Periodic Reports group for assigned projects and products.
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