Pharmacovigilance Specialist — PV & Compliance

BTG Pharmaceuticals (now SERB Pharmaceuticals); Paris; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

SERB Pharmaceuticals in Paris is seeking a Pharmacovigilance Officer to manage PV activities including case handling, signal management, and audits. The role requires a scientific degree and at least 3 years of PV experience, with strong English and familiarity with safety databases.

You will collaborate across regulatory, quality, and medical affairs to ensure patient safety and compliance. Join a global specialty pharma company committed to life-saving medicines, with a team-oriented culture

Qualifications

• 3+ years’ experience in pharmacovigilance or Materiovigilance.
• Ability to review, interpret, and analyze PV/MV cases.
• Proficiency in medical English to read, write, and translate data.

Responsabilités

• Participate in PV routine case management activities and exchanges with partners.
• Contribute to signal management and aggregate reports.
• Support vigilance data migration activities after acquisitions.
• Draft and update quality documents and CAPAs, Change Controls, and deviations.
• Participate in audits/inspections (back & front rooms) as needed.
• Maintain the PSMF and its appendices; coordinate with PV vendors and partners.

Connaissances

Pharmacovigilance

Safety databases

Medical English

GVP modules

PV case management

Formation

Scientific graduation

Outils

Safety databases

Description du poste

SERB Pharmaceuticals in Paris is seeking a Pharmacovigilance Officer to manage PV activities including case handling, signal management, and audits. The role requires a scientific degree and at least 3 years of PV experience, with strong English and familiarity with safety databases.

You will collaborate across regulatory, quality, and medical affairs to ensure patient safety and compliance. Join a global specialty pharma company committed to life-saving medicines, with a team-oriented culture