PV Officer (senior level position)

Job Description

At PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trials to large, generic post-marketing teams. We are always looking for proactive, capable, and motivated individuals who aim to surpass any target set in front of them.

The PV Officer should be a Life science / biomedical background graduate or have other healthcare-related degree qualifications (chemistry, biology, biotechnology, veterinary science, etc.) and have demonstrated strong experience with several years in case processing. The PV Officer will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

Responsibilities include:

1. Processing of 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 in accordance with client-specific requirements and timelines. As a key member, there is an expectation to effectively cover all steps of a workflow cycle, except Medical Review.
2. Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations).
3. Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
4. Mentoring and training of new and more junior employees within the department, including procedure optimization and development.