Associate Scientific Director, Safety Evaluation and Risk Management

About the role

The role gives scientific leadership on product safety evaluation, benefit-risk management and pharmacovigilance across clinical development and post-marketing programmes.

What you will do

• Contribute to safety review and risk management for assigned products
• Assess safety data from trials, post-marketing sources and scientific literature
• Support global regulatory submissions and health authority interactions
• Draft and review replies to health authority requests for information
• Advise clinical development teams on protocols, safety and regulatory matters
• Spot emerging safety concerns and recommend actions within cross-functional governance

What they look for

• An advanced scientific or healthcare degree such as PhD, PharmD, MS, NP or RN
• Substantial experience in clinical development, drug safety or pharmacovigilance
• Experience answering health authority requests for information
• Strong protocol support and regulatory background
• Excellent analytical, scientific writing and communication skills
• Fluent English and ability to work independently in global teams

Nice to have

• Oncology experience
• Interaction with FDA, EMA, PMDA and other regulators
• Support of global development programmes