We are seeking a Medical Director, Pharmacovigilance to provide clinical/scientific/PV expertise to lead a full range of core medical safety activities, including benefit-risk strategies, risk management, and safety surveillance activities in support of Beam’s products throughout their lifecycle.
Requirements
- MD required, Board certification preferred with 15+ years of experience.
- 5+ years of pharmacovigilance experience; other relevant experience may be considered.
- Experience in cell or gene therapy preferred; experience in other serious conditions, including oncology, rare or fatal conditions will be considered.
- Experience as safety lead for asset/approved drug product e.g. Global Safety Lead with responsibility for PV documents including but not limited to DSUR/PBRER; IB and ICF safety sections; risk management strategies and plans.
- Oversight experience of global medical safety activities including asset / approved product level safety governance, operations and risk management strategies in pre and post marketing environments.
- Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EMA, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments.
- Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems.
- Knowledge of MedDRA dictionary with relevance to adverse event coding.
- Excellent knowledge of drug development process, including clinical trial methodology, medical terminology and general principles of clinical assessment of AEs.
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies.
- Experienced in supporting health authority interactions, both written and verbal.
- Ability to navigate fast-paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must.
- Demonstrates leadership and interacts collaboratively and effectively in a team environment (e.g. Clinical Operations, Clinical Science, Data Management, Medical Affairs) and with external vendors and stakeholders.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Excellent leadership and communication skills with ability to influence at all levels of the organization.
