PV Officer
PV Officer
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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 trial to large generic postmarketing 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 / bio medical background graduate or have 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 (postmarketing 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
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
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
