.We are PrimeVigilance (part of Ergomed Group, a specialised mid-size pharmacovigilance service provider established in 2008).
We are proud to have achieved global organic growth year after year, with staff based across Europe, North America, and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
PrimeVigilance provides first-class support to our small to large pharmaceutical and biotechnology partners maintaining long-lasting relationships and has become one of the global leaders in its field.
We cover all therapy areas including medical devices.
We love investing in our staff by providing an excellent training and development platform.
We value employee experience, well-being, and mental health, and we acknowledge that a healthy work-life balance is a critical factor for employee satisfaction and nurtures an environment from which high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patients' lives.
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 trials 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 or biomedical background graduate or other healthcare-related degree qualification (chemistry, biology, biotechnology, veterinary science, etc.)
and 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 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 / biomedical 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