Senior Director, Pharmacovigilance

3 weeks ago

Cambridge, United States Beam Therapeutics Inc. Full time

Position Overview:

Unique opportunity to join a growing Pharmacovigilance (PV) team working on cutting edge therapies in the gene editing space. This senior PV role will be responsible for oversight and management of activities pertaining to Beam's drug safety and pharmacovigilance and have line management responsibilities for PV scientist(s). In addition will be responsible for deliverables associated with assigned product(s).

Responsibilities:

* Management, mentorship, and development of PV Scientist(s)
* Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for the assigned product(s)
* 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
* Provide strategic direction for the PV department on initiatives such as functional service provider model and global safety database strategy

Qualifications:

* Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
* Minimum 12years' pharmaceutical industry experience, including a minimum of 8 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
* Gene therapy experience is not required
* Experience working on BLA/MAA filings is preferred

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