Manager, Pharmacovigilance
Philadelphia
Permanent
USD130000 - USD170000
Clinical Development
PR/552339_1752256642
Manager, Pharmacovigilance
The Pharmacovigilance Manager will support a variety of safety-related functions, including oversight of safety data, ensuring inspection readiness, and managing external PV service providers. This individual will be instrumental in maintaining a state of continuous audit preparedness and will work cross-functionally with teams aligned under the VP of Pharmacovigilance.
Core Responsibilities:
- Offer operational PV guidance to internal stakeholders.
- Develop, update, and oversee PV-related Standard Operating Procedures (SOPs).
- Ensure the organization remains prepared for audits at all times.
- Act as the liaison during audits and inspections, and assist in audit preparation.
- Oversee third-party PV vendors, monitor their performance, and address any issues.
- Contribute to the preparation and upkeep of the Pharmacovigilance System Master File (PSMF).
- Manage PV quality systems, including setting and tracking key performance indicators (KPIs) and compliance metrics.
- Draft safety-related queries to clarify clinical documentation.
- Collaborate with workflow leads to ensure timely case processing.
- Evaluate data from clinical, non-clinical, post-marketing, and literature sources.
- Provide support for licensing efforts, regulatory reviews, and internal audits.
- Represent PV in cross-functional and investigator meetings as needed.
- Maintain awareness of both local and international regulatory requirements.
- Partner with compliance and quality teams to uphold quality standards.
- Perform additional tasks as required.
Qualifications and Experience:
- Bachelor's degree in a life sciences or related field.
- At least five years of experience in PV operations.
- Proven experience preparing for audits and managing vendor readiness.
- Familiarity with EU PV regulations, including Local Person for Pharmacovigilance (LPPV) responsibilities.
- Skilled in tracking contracts, purchase orders, and related documentation.
- Experience managing vendors, including remote oversight.