Manager, Pharmacovigilance Safety Operations

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.

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

 
Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities