Executive Medical Director – Pharmacovigilance and Risk Management – Pvrm

Executive Medical Director – Pharmacovigilance and Risk Management – Pvrm

Requirements

• M.D. degree and a minimum of 10 years of post-residency experience; or, Equivalent combination of education and experience.
• 3+ years of clinical experience post-residency
• At least 10 years of experience of pharmacovigilance experience or other relevant experience (e.g., Clinical Research) in a pharmaceutical/biotechnology company.
• Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations.

Responsibilities

• Lead and develop the safety strategy for complex clinical development programs for oncology products in development or products with a marketing authorization.
• Create appropriate safety data analysis strategies across clinical studies for a product.
• Perform appropriate data interpretation on the performed safety analyses for a product.
• Set a clear strategy for key safety deliverables for the product (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
• Lead the cross-functional Benefit Risk Team for the assigned product and escalate important safety updates to the Benefit Risk Executive Committee in a timely fashion.
• Lead the development of core safety documents, which characterize the safety profile of the product appropriately.
• Lead proactive safety data reviews and anticipate safety concerns for the assigned product.
• Oversee the development of safety data evaluations and summaries in the global periodic safety aggregate reports for the product.
• Present safety data and provide safety expertise on the product during key meetings (e.g., with Health Authorities, Data Safety Monitoring Boards and Investigators).
• Develop risk management strategies and monitoring plans for risk management effectiveness for the product.
• Co-lead the benefit-risk assessment for the product with other functions.

Preferred Qualifications

• Board Certification (if US) preferred
• Pharmacovigilance experience in Oncology is a plus.
• Prior project and team leadership/management experience is preferred.