Manager, Pharmacovigilance Safety Operations
ICONMA
Manager, Pharmacovigilance Safety Operations
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
Vacancy posted 13 hours ago
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