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Pharmacovigilance Specialist
2 semanas atrás
**About Us**
We are part of Ergomed Group, a specialist pharmacovigilance service provider. Established in 2008, we have achieved global organic growth year after year.
Our staff is based across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
We provide first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in our field.
We cover all therapy areas including medical devices.
We invest in our staff by providing an excellent training and development platform.
We value employee experience, well-being, and mental health, acknowledging that a healthy work-life balance is critical for employee satisfaction and nurtures an environment from which high-quality client service can be achieved.
Job Description
PV Officers are independent case processing team members who manage various 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 PV Officer should have a life science / biomedical background graduate or 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 work as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.
Responsibilities
- 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.
- Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations)
- Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc)
Requirements
Life science / biomedical background graduate or other healthcare-related degree qualification (chemistry, biology, biotechnology, veterinary science, etc.)
Demonstrated experience with several years in case processing
Benefits
We offer an excellent training and development platform
We value employee experience, well-being, and mental health
