EEA Deputy QPPV — Pharmacovigilance Leader

Bristol Myers Squibb EU Policy; Wien; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb is seeking a Senior Director, EEA Deputy QPPV to oversee pharmacovigilance activities in the EU/EEA. The role involves ensuring safety, regulatory compliance, and QPPV office governance.

The position requires extensive experience in pharmacovigilance, regulatory science, and a track record with PSURs/PBRERs, with occasional travel to BMS sites and health authorities.

Qualifikationen

• Strong organizational and facilitation abilities with multidisciplinary teams.
• Excellent interpersonal and communication skills across functions and regions.
• Deep knowledge of pharmacovigilance and regulatory obligations (EEA/Global).
• Ability to influence decisions and drive risk management.
• Experience with PSURs/PBRERs and regulatory submissions.

Aufgaben

• Develop and maintain safety profiles for assigned products; review PSURs, PBRERs, EU RMPs, and other safety documents.
• Provide scientific input to PASS and PAES protocols and related documents; review amendments and final study reports.
• Ensure timely responses to competent authorities and EMA information requests.
• Support audits and inspections related to the QPPV Office and pharmacovigilance system.

Kenntnisse

Organizational skills

Facilitation

Interpersonal skills

Communication

Ausbildung

MD/PharmD/PhD

Jobbeschreibung

Bristol Myers Squibb is seeking a Senior Director, EEA Deputy QPPV to oversee pharmacovigilance activities in the EU/EEA. The role involves ensuring safety, regulatory compliance, and QPPV office governance.

The position requires extensive experience in pharmacovigilance, regulatory science, and a track record with PSURs/PBRERs, with occasional travel to BMS sites and health authorities.