The Senior Director of Safety, Pharmacovigilance, and Risk Management has the overall medical safety responsibility for Arena product(s). This individual will lead completion of key safety related documents including IBs, safety aggregate reports, regulatory queries, safety sections of study reports and ISS’. This individual will also ensure the assessment of individual case reports, narratives and coding as well as lead the cross functional safety teams and committee. The Senior Director will partner with the VP of Safety and Pharmacovigilance to ensure proactive benefit-risk management of all compounds in the Arena portfolio.
What you'll dive into
- Overall safety responsibility for assigned molecules;
- Perform (as needed) single case assessments of 15-day expedited reports and SAEs for causality and assessment and write ASIMEs (Analyses of Similar Events);
- Support development of relevant policies, SOPs and Work Instructions;
- Write (as needed) and/or review periodic reports, DSURs, PBRERs, DRMPs, Annual Reports, etc;
- Write (as needed) and/or review safety documents, Risk Management Plans, SmPC, Label, Company Core Safety Information, RSI, etc.
- Provide strategic safety input to regulatory responses;
- Lead the medical safety group as well in product level safety governance (SMT) and communicate with VP Head of Safety for safety oversight;
- Provide safety related responses with cross-functional representatives;
- Ensure review and analysis of literature, AESIs, collaborate with Clinical/Medical colleagues for AE trending;
- Coordinate and communicate activities with other groups in drug safety and in the company globally.
What we expect
- MD (Doctor of Medicine) or equivalent required (e.g., D.O, D.V.M, D.P.M, D.M.D, etc.)
- Minimum 5 years of experience in medical drug safety in the pharmaceutical industry
- Substantial knowledge and experience with drug safety medical assessments in clinical trials and post market (desired)
- Understanding of how global drug safety related regulations are applied
- Experience in leading cross functional drug safety team
- Strong written and oral scientific communication skills
- Strong scientific analytical reasoning skills
- Behavioral competencies necessary to work and lead within a matrix environment
- Understanding of drug development process, with knowledge of design and execution of randomized clinical trials
- Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
- Understanding of regulatory requirements for safety assessment and action through the life cycle of a drug product.
- Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
What you’ll get
- To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
- Opportunities to learn and contribute creative solutions
- Comprehensive health insurance ($0 premium on select medical plans)
- Matching 401k retirement plan
- Paid time off and holidays including a Summer & Winter break
- Company celebrations