Senior Pharmacovigilance Officer

About the role

PrimeVigilance is a global pharmacovigilance specialist whose teams help clients navigate complex regulations while keeping patient safety at the centre of every decision, from early development through to post-marketing surveillance. PV Officers are independent case processing team members who manage a variety of case processing services with full accountability, working in teams of different sizes, from small clinical trial teams to large generic post-marketing teams. The role is performed as part of a project team, carrying out and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

Key responsibilities

• Process Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and client-specific requirements and timelines
• Cover all steps of the workflow cycle except Medical Review
• Manage independent SAE/SUSAR submissions, unblinding and clinical trial reconciliations
• Prepare database outputs for periodic reporting (PBRER, DSUR, PADER, etc.)
• Mentor and train new and more junior employees, including procedure optimisation and development

Required profile

• Life science or biomedical background, such as a healthcare-related degree (chemistry, biology, biotechnology, veterinary science)
• Demonstrated experience in pharmacovigilance case processing over several years
• Advanced English skills, verbal and written, at least C1

Required skills

• Time and issue management, delegation, organisation and multitasking with good attention to detail
• Strong interpersonal and communication skills