Director, Pharmacovigilance
Beam Therapeutics
August 25, 2026
Remote friendly (Cambridge, MA)
United States
$210,000 - $260,000 USD yearly
Operations
Responsibilities:
- Provide strategic scientific and operational pharmacovigilance (PV) support for Beam products.
- Oversee day-to-day safety monitoring and safety operations for clinical trials for assigned product(s).
- Serve as PV subject matter expert for clinical development teams and cross-functional forums.
- Triages/processes/submits/distributes safety reports per global requirements and SOPs; assess individual case safety reports (ICSRs), including Analysis of Similar Events.
- Contribute to development/review of PV-related clinical, regulatory, and scientific documents (e.g., protocols, informed consents, study reports, manuscripts, abstracts, CRFs, SAPs).
- Facilitate Safety Management Committee/governance meetings; coordinate materials, outputs, agendas, and minutes.
- Support signal detection with signal assessment/validation, cross-functional signal review, action/communication plans, regulatory responses, and product risk management.
- Oversee vendor activities for ICSRs and case processing, aggregate reports (DSUR/PSUR/PADERs), expedited reporting, safety database configuration/maintenance, KPIs, and CAPA.
- Lead DSURs and other aggregate safety reporting; ensure reporting compliance.
- Communicate with partners/vendors for timely safety report exchange; develop and deliver PV training.
- Support inspection/audit readiness, TMF support, PV filing systems; lead escalation/investigation of safety/non-compliance and corrective actions.
- Develop/support SOPs and PV process documents; manage PV agreements with partners.
- Maintain Reference Safety Information (RSI) (e.g., CCDS/CCSI/IB) and support PV vendor transition/migration.
Qualifications:
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent; PV competence; healthcare degree preferred (NP, PA, RN/BSN, PharmD, MD).
- 10+ years pharma industry experience, incl. 5+ years PV.
- Knowledge of MedDRA, AE clinical assessment, global PV regulations (FDA/EU/GVP/ICH).
- Working knowledge of ARGUS and ARISg (or similar safety databases) and eDC systems.
- Experience with cumulative safety data review and pre-/post-aggregate safety report authoring.
- Strong execution, documentation, communication, cross-functional collaboration, prioritization, and organizational/project management.
- Some domestic/international travel; onsite 1–3 days/week.
- Provide strategic scientific and operational pharmacovigilance (PV) support for Beam products.
- Oversee day-to-day safety monitoring and safety operations for clinical trials for assigned product(s).
- Serve as PV subject matter expert for clinical development teams and cross-functional forums.
- Triages/processes/submits/distributes safety reports per global requirements and SOPs; assess individual case safety reports (ICSRs), including Analysis of Similar Events.
- Contribute to development/review of PV-related clinical, regulatory, and scientific documents (e.g., protocols, informed consents, study reports, manuscripts, abstracts, CRFs, SAPs).
- Facilitate Safety Management Committee/governance meetings; coordinate materials, outputs, agendas, and minutes.
- Support signal detection with signal assessment/validation, cross-functional signal review, action/communication plans, regulatory responses, and product risk management.
- Oversee vendor activities for ICSRs and case processing, aggregate reports (DSUR/PSUR/PADERs), expedited reporting, safety database configuration/maintenance, KPIs, and CAPA.
- Lead DSURs and other aggregate safety reporting; ensure reporting compliance.
- Communicate with partners/vendors for timely safety report exchange; develop and deliver PV training.
- Support inspection/audit readiness, TMF support, PV filing systems; lead escalation/investigation of safety/non-compliance and corrective actions.
- Develop/support SOPs and PV process documents; manage PV agreements with partners.
- Maintain Reference Safety Information (RSI) (e.g., CCDS/CCSI/IB) and support PV vendor transition/migration.
Qualifications:
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent; PV competence; healthcare degree preferred (NP, PA, RN/BSN, PharmD, MD).
- 10+ years pharma industry experience, incl. 5+ years PV.
- Knowledge of MedDRA, AE clinical assessment, global PV regulations (FDA/EU/GVP/ICH).
- Working knowledge of ARGUS and ARISg (or similar safety databases) and eDC systems.
- Experience with cumulative safety data review and pre-/post-aggregate safety report authoring.
- Strong execution, documentation, communication, cross-functional collaboration, prioritization, and organizational/project management.
- Some domestic/international travel; onsite 1–3 days/week.