Pharmacovigilance Specialist – Drug Safety

About the role

Merck is seeking a Pharmacovigilance Specialist to lead local drug safety activities. The role operates with a high degree of autonomy, ensuring compliance with regulations and company policies while collaborating with internal teams, business partners, and health authorities.

Key responsibilities

• Execute local pharmacovigilance processes in line with global standards and applicable regulations.
• Manage adverse event cases from intake through assessment, follow‑up, and reporting.
• Coordinate aggregate safety reports and support post‑marketing safety monitoring programs.
• Participate in audits and inspections, providing preparation, documentation support, and CAPA follow‑up.
• Develop and maintain local PV procedures and contribute to continuous improvement initiatives.
• Support implementation of risk minimisation measures and Risk Management Plans.
• Act as a local PV subject‑matter expert, guiding internal teams and contributing to cross‑functional projects.
• Ensure compliance with literature review, health authority monitoring, and document management activities.

Required profile

• Professional experience in pharmacovigilance with a strong focus on quality and compliance.
• Ability to work independently, influence cross‑functional teams, and maintain a patient‑safety mindset.
• Adaptable and detail‑oriented, capable of supporting business continuity and training initiatives.

Required skills

• Adverse Event Reporting
• Clinical Trial Management
• Data Analysis
• Data Management
• Drug Safety Surveillance
• Pharmacovigilance
• Regulatory Communications
• Regulatory Compliance
• Risk Management
• Risk Models
• Safety Management
• Periodic Safety Update Reports
• Quality Control Management
• Veterinary Products