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.