Director/Sr. Director, Pharmacovigilance

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview: 

This is a unique opportunity to join a growing Pharmacovigilance team. This PV expert will start as an individual contributor and may have opportunity to grow his/her team over time. Responsibilities include providing strategic scientific and operational PV support for products in the Beam portfolio. 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. In addition, she/he will also function in a company matrix environment collaborating with several key groups including but not limited to Clinical Operations, Biometrics, Data Management, Clinical Development, Clinical Science, Regulatory Affairs, Medical Writing, Nonclinical, and Quality.

Responsibilities:

• Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for assigned product(s).
• Provide PV subject matter expertise on clinical development teams and other cross-functional forums throughout the company.
• Ensure that safety reports for assigned products are triaged, processed and submitted/distributed as required per global requirements and applicable SOPs.
• Perform individual case safety report assessments for clinical trial safety reports, including review of Analysis of Similar Events, as applicable.
• Manage PV vendor-related activities including vendor selection, contracts, scope of work, budgets, safety management plans and other similar process documents, training and filing documentation, in support of full lifecycle PV activities.
• Contribute to the development and review of clinical, regulatory, and scientific documents including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans, and/or other documents as needed.
• Facilitate internal cross-functional Safety Management Committee and/or other safety governance/review meetings; including coordinating materials, data outputs and presentation, agenda and minutes.
• Work closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents; leading cross functional teams to assess safety signals; preparing action and communication plans to mitigate/manage product risks; responding to safety related regulatory requests; developing and maintaining product risk management plans.
• Support and oversee all vendor activity related to individual case safety reports (ICSR) and case processing, aggregate reports (DSUR, PSUR, and PADERs), expedited reporting, safety database configurations/maintenance, compliance, KPIs, and CAPA management.
• Serve as lead for Quality and Compliance within PV and ensure PV department inspection and/or audit readiness, including TMF support and organization of PV filing systems e.g. SharePoint.
• Manage/contribute to PV agreements with license partners and/or other parties as required, and support such alliances from operational perspective.
• Serve as PV lead for escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions, SMP non-compliance, and the implementation of appropriate corrective actions, as needed.
• Develop or support development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions
• Partner with Quality to establish and maintain training plans and curricula for cross functional team.
• Contribute to the dev