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Clinical R&D

Director, Pharmacovigilance Scientist

  • Cambridge, MA
  • Added
Asset 1

Position Overview:

Unique opportunity to join a growing Pharmacovigilance team. This PV expert will be an individual contributor to start with the opportunity to grow his/her team over time. Responsibilities include providing strategic and operational PV support for several Beam products in the pre-market space. 

Responsibilities:

  • Oversight of day to day safety monitoring activities and safety operations of clinical trials for the assigned product.
  • Provide PV subject matter expertise on Clinical Development Teams and other cross-functional platforms throughout the company.
  • Facilitate internal cross-functional Safety Management Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda.
  • Review and provide PV input for development of protocols, IBs, CSRs and other relevant study documents.
  • Project lead for DSURs and subject matter contributor to other aggregate documents such as Investigator Brochure.
  • Oversight of vendor specific to PV deliverables.

 Qualifications:

  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV.
  • Minimum 8 years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV.
  • Knowledge of MedDRA terminology and its application.
  • 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 work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
  • Independently motivated, detail oriented and good problem solving ability.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
  • Excellent communication skills and ability to influence across multiple functions.
  • Be ready to embrace the principles of Beam.

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