Director, Pharmacovigilance Job at Beam Therapeutics (Cambridge)

Job Description

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.

Job Responsibility

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
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

Requirements

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)
10+ 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
Candidates are expected to come onsite 1-3 days per week

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Director, Pharmacovigilance

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