Director, Pharmacovigilance

The role

This individual contributor will provide strategic scientific and operational pharmacovigilance support for products in the Beam portfolio. The role involves managing safety reports, signal management, PV organization, and vendor management throughout the product lifecycle.

What you will do

• Oversight of day-to-day safety monitoring activities and safety operations of clinical trials.
• Provide PV subject matter expertise on clinical development teams and cross-functional forums.
• Ensure safety reports are triaged, processed, and submitted per global requirements and SOPs.
• Perform individual case safety report assessments for clinical trial safety reports.
• Contribute to the development and review of clinical, regulatory, and scientific documents.
• Facilitate internal cross-functional Safety Management Committee and safety governance meetings.
• Support signal detection activities including preparing assessments and managing product risk plans.
• Oversee vendor activity related to ICSR, aggregate reports, and safety database maintenance.
• Lead DSURs, 6-monthly line listing reports, or other aggregate safety reports.
• Develop training materials and conduct training on PV related content.

Required qualifications

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV.
• Typically 12+ years pharmaceutical industry experience, including a minimum of 5 years 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 including FDA, EU, GVP, and ICH guidelines.
• 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 information.
• 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 manage and prioritize multiple projects and demands simultaneously.
• Excellent communication, interpersonal, and writing skills.

Nice to have

• Healthcare professional degree (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent).

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.