Beam Therapeutics
Director, Pharmacovigilance
Cambridge, MA · Director · Full-time
Sponsorship not specified$210k-$260kDetected 40 days ago
StatisticsProject ManagementProcess ImprovementVendor ManagementClinical TrialsFDA RegulatoryCRISPRPharmacovigilanceLeadershipCommunicationProblem SolvingPublic SpeakingWritingEpidemiologyRegulatory Affairs
About the role
- 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 with integrated gene editing, delivery and internal manufacturing capabilities.
- This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs.
Responsibilities
- 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.
- preparing action and communication plans to mitigate/manage product risks
- 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.
Requirements
- 10+ years' pharmaceutical industry experience, including a minimum of 5 years' experience in PV.
- 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.
- 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.
- Excellent communication, interpersonal, and writing skills, including ability to work effectively cross-culturally and cross-functionally with internal and external stakeholders.
- Some international/domestic travel may be required.
- 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).
- 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.
- Thorough understanding of the drug development process and context applicable to safety surveillance activities.
- Ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure.
- Independently motivated, detail oriented and good problem-solving ability.
Nice to have
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
Benefits
- 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.
- Work closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents
Apply directly at Beam Therapeutics →Create a free account for alerts like thisView Beam Therapeutics immigration profile
This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.