Senior PV Specialist - Belgium & Luxembourg

MSD; Brussel Hoofdstad; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

32 vacation days

Health insurance plan

Bonus

Excellent pension

Eco cheque

Training modules

Zusammenfassung

MSD is seeking a Senior Pharmacovigilance Specialist to contribute to daily PV activities in Brussels, covering Belgium and Luxembourg. You will manage PV intake, local agreements, due diligence, risk minimization, audits, and inspections, while coordinating with Clinical Ops, Regulatory Affairs, and other functions to ensure PV compliance.

The role requires a Master’s or Bachelor’s in health or life sciences and at least two years in PV or regulatory affairs, with language fluency in French or

Qualifikationen

• Master’s/ bachelor’s degree in health, life science, medical science, regulatory affairs or equivalent by experience.
• At least two years of industry experience in pharmacovigilance or regulatory affairs in a pharmaceutical company/health authorities’ organization/ CRO/ consulting company providing pharmacovigilance services.
• Knowledge of pharmacovigilance regulations in Belgium and Luxembourg and experience in interacting with PV auditors and preferably PV inspectors.
• Fluency in at least 1 local language - French or Dutch; Dutch being a strong preference, and some working knowledge of the second language highly desirable.

Aufgaben

• PV intake, management and negotiation of local PV agreements.
• Local due diligence activities.
• Implementation and oversight of risk minimization measures.
• Participation in audits and inspections and related readiness activities.
• Developing local procedures for the department to ensure quality PV data and processes.
• Responsible for day-to-day adverse events case management.
• Interfacing with colleagues from different functional areas to ensure alignment on issues impacting PV.
• Supporting local initiatives and programs to ensure compliance with PV requirements.
• Serving as the point of contact for the local Health Authority for PV related questions.

Kenntnisse

Adaptability

Adverse Event Report

Auditing

Compliance Monitoring

Data Analysis

Decision Making

Drug Safety Surveillance

Pharmaceutical Regulatory Compliance

Regulatory Compliance

Regulatory Reporting

Risk Management

Strategic Planning

Training and Development

Veterinary Products

Ausbildung

Master’s/ bachelor’s degree in health, life science, medical science, regulatory affairs or equivalent by experience

Tools

MS-Office

Jobbeschreibung

MSD is seeking a Senior Pharmacovigilance Specialist to contribute to daily PV activities in Brussels, covering Belgium and Luxembourg. You will manage PV intake, local agreements, due diligence, risk minimization, audits, and inspections, while coordinating with Clinical Ops, Regulatory Affairs, and other functions to ensure PV compliance.

The role requires a Master’s or Bachelor’s in health or life sciences and at least two years in PV or regulatory affairs, with language fluency in French or