EU remote
Pharmacovigilance Officer (senior level position)
About this role
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 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 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:   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 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 When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.     We are diverse in many ways, yet our values unite us.