Director/Sr. Director, Pharmacovigilance

Role Summary

Director/Sr. Director, Pharmacovigilance overseeing safety monitoring, signal management, and PV operations across Beam Therapeutics products. Lead in a matrix environment with cross-functional collaboration, initially as an individual contributor with potential to grow a team.

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 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.
• 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.
• Oversee 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.
• Maintain knowledge of disease indications for assigned Beam products.
• Participate in the development of PV organizational strategy, goals, and objectives and assist with the implementation and training to support department goals and initiatives.
• Support organizational leadership in assigned activities and initiatives and actively participate in daily pharmacovigilance activities with a "can-do, hands-on, positive attitude."
• Other duties, as assigned.

Qualifications

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV. Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent).
• 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.
• Be ready to embrace the principles of Beam.