Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The Director of Pharmacovigilance will contribute to a full range of pharmacovigilance activities, including but not limited to, the oversight and management of safety reports and safety data, signal management activities, PV organization and process development, inspection readiness, PV vendor management, and operational support for Beam products throughout the lifecycle.
Requirements
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV.
- 15+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV.
- Knowledge of MedDRA dictionary, clinical trial methodology, medical terminology, and general principles of clinical assessment of AEs.
- Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, 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.
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data.
- Experience in the preparation and authoring of pre- and post- aggregate safety reports.
- Thorough understanding of the drug development process and context applicable to safety surveillance activities.
- Ability to execute and follow-through to completion and documentation.
- Ability to navigate fast-paced and dynamic work environment; ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure.
- Excellent communication, interpersonal, and writing skills, including ability to work effectively cross-culturally and cross-functionally with internal and external stakeholders.
- Independently motivated, detail oriented and good problem-solving ability.
- Excellent organizational and prioritization skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Strong organizational and project management skills.
- Some international/domestic travel may be required.
Benefits
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
