Senior Pharmacovigilance Specialist – Belgium and Luxembourg M/F/D
Core
Managing day-to-day adverse event case management, local PV agreements, due diligence, and risk minimization measures for Belgium and Luxembourg.
Role type
Senior Pharmacovigilance Specialist
Builds
Local PV processes and compliance for the BeNeLux region
Domain
Pharmaceutical regulatory compliance and drug safety
Required skills
Adverse Event Report management, Auditing, Compliance Monitoring, Data Analysis, Drug Safety Surveillance, Regulatory Reporting, Risk Management
Preferred skills
PV Inspector interaction, Digital interface implementation, Strategic Planning
Technologies
MS-Office
Responsibilities
Developing local procedures for quality PV data, managing adverse events, interfacing with Clinical Trial Operations and Regulatory Affairs, serving as point of contact for local Health Authorities, participating in audits and inspections.
Seniority
Senior, hands-on IC