Director, Pharmacovigilance

Director, Pharmacovigilance

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.

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.

Lead for DSURs, 6-monthly line listing reports or other aggregate safety reports and oversee reporting compliance.

Communicate with partner companies, vendors, and internal group regarding processing and timely exchange of safety reports.

Develop training materials and conduct training on PV related content, including presentations at Investigator Meetings and/or Site Initiation Visits, Company trainings, or other trainings, as needed.

Contribute to PV vendor-related activities including vendor selection, contracts, scope of work, budgets, safety management plans and other similar process documents, and training and filing documentation, in support of full lifecycle PV activities.

Contribute to 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.

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.

Manage/contribute to PV agreements with license partners and/or other parties as required, and support such alliances from operational perspective.

Contribute to training plans and curricula for cross functional team.

Contribute to the development of standards and templates e.g. data outputs, reporting forms, guidance's.

Contribute to the development and maintenance of Reference Safety Information (RSI) including Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), Investigator Brochure (IB), and/or other product labeling.

Support safety database migration activities during PV vendor transitions, and develop process documentation and plans related to PV vendor transitions, as applicable.

Participate in departmental and cross functional risk assessment and process improvement initiatives.

Beam Therapeutics is hiring for this role on CareerPlace.

Apply on the company website through Beam Therapeutics.

Imported from employer careers page. Source ref: 8f1c345557c2.