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.
- 10+ 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.
