Executive/Senior Executive-Pharmacovigilance

Hetero


Date: 2 weeks ago
City: Hyderabad, Telangana
Contract type: Full time
Roles & Responsibilities:

Handling of PSMF experience

  • Plan and maintain schedules for PSMF
  • Maintain list of core and annexures of PSMF for various regions.
  • Coordinate preparation of core PSMF documents in collaboration with internal and external stakeholders.
  • Coordinate with QPPVs to ensure accurate representation of PV system in line with regulatory requirements.
  • Track timely provision of information from stakeholders for PSMF production, escalating issues to the reporting manager or QPPV. Format and publish final PSMF, ensuring consistency.
  • Coordinate preparation, review, approval and signatures of PSMF and Summary Pharmacovigilance System Master File (SPSMF).
  • Maintain PSMF trackers, and the PSMF document in archive and at agreed web sites.
  • Support during audit and inspection

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