Pharmacovigilance Specialist
hace 4 semanas
Job Description
At Ergomed Group, we are seeking a highly skilled Pharmacovigilance Specialist to join our team. As a key member of our pharmacovigilance department, you will be responsible for managing a variety of case processing services with full accountability.
You will work with teams of different sizes, from small clinical trials to large, generic post-marketing teams. We are looking for proactive, capable, and motivated individuals who aim to surpass any target set in front of them.
The ideal candidate will have 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.
As a Pharmacovigilance Specialist, you will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of Ergomed Group.
You are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion.
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, Ergomed Group procedures, and in accordance with client-specific requirements and timelines.
- 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
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