Medical Director, Safety Evaluation and Pharmacovigilance

About the role

A remote contract role giving medical leadership to safety evaluation, benefit-risk assessment and risk management for products in development and on the market. The physician in this seat works independently on safety questions and regulatory exchanges.

What you will do

• Direct safety evaluation and benefit-risk analysis for the products assigned
• Back pharmacovigilance and risk management work for marketed and developing products
• Help shape regulatory filings and exchanges with health authorities
• Draft and check well-grounded replies to authority requests for information
• Interpret clinical and safety data to guide regulatory and business choices
• Take part in cross-functional safety governance and raise emerging risks

What they look for

• A medical degree or an equivalent physician credential
• Substantial background in clinical development, drug safety or pharmacovigilance
• Prior work answering requests for information from health authorities
• Solid grasp of benefit-risk assessment and safety evaluation
• Experience backing regulatory submissions and agency interactions
• Excellent scientific writing and communication, with fluent English

Nice to have

• Oncology background is very welcome though not essential
• Familiarity with FDA, EMA, PMDA and other regulators
• Experience with worldwide development programmes

Benefits

• Home internet allowance of up to 50 EUR gross
• Health insurance for the worker