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.

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