Manager, Pharmacovigilance Safety Operations

KEY ROLE AND 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

KNOWLEDGE, SKILLS AND ABILITIES:

• 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

PREFERRED EDUCATION:

• Degree in Pharmacy, Nursing, Biosciences or equivalent healthcare degree with pharmaceutical industry background

PREFERRED EXPERIENCE:

• 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