Assist in maintaining pharmacovigilance key performance indicators and metrics, with specific focus on expedited report submissions and subsequent investigator notifications. Interface with the Study Management Team, safety service provider, and medical safety reviewer to maintain safety processes supporting assigned studies.
Numbers & Facts
Location
Bothell, WA
Description
Our Client, a Clinical-Stage Cell Therapy company, is looking for a Manager, Pharmacovigilance Safety Operations for their Bothell, WA/ /CA/Remote location.
Responsibilities:
Represent Patient Safety as a Study Management Team member
Interface with the Study Management Team, safety service provider, and medical safety reviewer to maintain safety processes supporting assigned studies
Assist with safety data case processing oversight
Manage review and revision of safety language in relevant study documents
Prepare and maintain safety management plans
Contribute to service provider oversight
Assess changes to the ICF safety information by sites and IRBs
Assist with the preparation and management of aggregate reports such as the Development Safety Update Report
Prepare and contribute to written processes supporting pharmacovigilance activities
Assist in maintaining pharmacovigilance key performance indicators and metrics, with specific focus on expedited report submissions and subsequent investigator notifications
Monitor pharmacovigilance-related service provider compliance
Contribute to the safety assessment strategy and aggregate safety review
Provide pharmacovigilance-specific guidance for service provider audit planning
Assist with authoring pharmacovigilance standard operating procedures
Other activities as assigned
Requirements:
Solid foundation in GCP and GVP regulations
Ability to work independently and effectively in a remote-based, multifunctional team
Experience working with and managing safety service providers
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 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
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
Excellent oral and written communication skills
Degree in Pharmacy, Nursing, Biosciences or equivalent healthcare degree with pharmaceutical industry background
At least 5+ years' experience in pharmacovigilance and clinical development; oncology experience is preferred
Direct experience in a small biotech environment in addition to large pharmaceutical
experience is a significant plus
Immuno-oncology therapeutic area experience or equivalent required; CAR-T
experience preferred
Demonstrated experience managing PV service providers