Full-Time PV Officer (Senior Level)

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 trial 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 have a Life science / bio medical background graduate or other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) and have demonstrated experience 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:

• 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.
• Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations).
• Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
• Mentoring and training of new and more junior employees within the department, including procedure optimization and development.

Required qualifications:

• Life science / bio medical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.
• Demonstrated case processing experience.
• Time and issue management, delegation, organization, and multitasking skills with good attention to detail.
• Strong interpersonal and communication skills.
• Advanced English skills, both verbal and written, at least C1.

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