Job Title: Junior PV Officer/PV Officer
Location: Remote (Employees can work remotely)
Job Type: Full-time
Department: ICSR Management
About the Company:
PrimeVigilance, part of Ergomed Group, is a leading global pharmacovigilance service provider established in 2008. With a presence across Europe, North America, and Asia, the company offers specialized services in medical information, pharmacovigilance, regulatory affairs, and quality assurance. PrimeVigilance serves small to large pharmaceutical and biotechnology companies, establishing long-lasting relationships. The company values employee well-being and invests in professional growth while maintaining a healthy work-life balance.
Job Responsibilities:
Case Processing:
Manage and process Individual Case Safety Reports (ICSRs) from all sources (post-marketing and clinical trials, including medical devices and combination products)
Ensure compliance with applicable regulations, PrimeVigilance procedures, and client-specific requirements and timelines
Cover all steps of the workflow cycle, excluding Medical Review
Independent SAE/SUSAR Management:
Handle submissions, unblinding, and clinical trial reconciliations
Reporting and Mentoring:
Prepare database outputs for periodic reporting (e.g., PBRER, DSUR, PADER)
Mentor and train new or junior employees within the department
Contribute to procedure optimization and development
Required Qualifications:
Education:
Life science or biomedical background (e.g., chemistry, biology, biotechnology, veterinary science)
Demonstrated experience in pharmacovigilance case processing
Skills and Experience:
Proven experience in case processing
Strong time management, organizational, and multitasking skills with a focus on attention to detail
Excellent interpersonal and communication skills
Advanced English proficiency (both verbal and written) at least C1
Additional Information:
PrimeVigilance fosters a diverse, inclusive, and human-centric work environment where all employees, regardless of background, can grow and thrive.
The company offers training and career development opportunities, a friendly and supportive working environment, and the chance to collaborate with a global team.
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