Associate Director Safety Sciences

Responsibilities

• Perform cumulative safety data reviews across trials or programs to assess safety profiles and identify emerging risks or trends
• Oversee safety surveillance activities, including signal detection, literature reviews, and aggregate safety data analysis
• Author periodic reports such as DSURs, PSURs, PBRERs, and Risk Management Plans (RMPs)
• Collaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making
• Provide input into regulatory submissions and respond to Health Authority queries with scientifically sound responses
• Act as a primary safety contact for clinical trial documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and Informed Consent Forms (ICFs)
• Serve as a Subject Matter Expert during audits and inspections for key safety processes
• Mentor new team members by providing training on core safety processes

Requirements

• Advanced degree in life sciences or healthcare (PhD or post-doctoral pharmacovigilance certification preferred)
• At least 5 years of experience in clinical research with significant exposure to pharmacovigilance
• Mandatory therapeutic area experience in oncology
• Expert knowledge of pharmacovigilance laws, regulations, and GCP/GVP guidelines
• Proven experience in designing and implementing clinical safety processes and reporting safety data from clinical trials
• Fluency in written and spoken English
• Strong communication skills with the ability to influence through scientific expertise

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are a community of innovators and scientists working to address high medical needs, such as cancer and infectious diseases, to improve health worldwide.