PSMF & Compliance Manager (Pharmacovigilance)

TL;DR

PSMF & Compliance Manager (Pharmacovigilance): Ensuring the company's pharmacovigilance system meets regulatory requirements with an accent on PSMF maintenance and KPI tracking. Focus on evaluating PV regulations, updating the Pharmacovigilance System Master File, and optimizing system performance metrics.

Location: Hybrid (Parma, Italy)

Salary: from €46,000

Company

Global research-focused biopharmaceutical group with 90 years of experience operating in over 30 countries.

What you will do

• Evaluate pharmacovigilance regulations and guidelines for applicability to the PV system and support global implementation.
• Maintain and ensure timely updates of the Pharmacovigilance System Master File (PSMF).
• Define and propose improvements for pharmacovigilance KPIs to increase system efficiency.
• Track metrics, trends, and compliance issues on a periodic basis.
• Deliver performance reports to stakeholders for evaluation of the Global PV system.

Requirements

• Master Degree in life sciences, pharmacy, or related fields.
• Minimum 5 years of experience in international Pharmacovigilance within Pharmaceutical, Biotechnology, or CRO industries.
• Strong skills in decision making, effective judgement, and problem solving.
• Effective communication and teamwork abilities.

Culture & Benefits

• Competitive salary package with an annual performance bonus scheme.
• Comprehensive healthcare programs and private medical insurance.
• Flexible hybrid working arrangements.
• Robust relocation support and tax assistance for foreign colleagues.
• Pension, wellbeing, and flexible benefits programs.