Posted 9 hours ago
Pharmacovigilance Officer
PrimeVigilance
Requirements
Life science or biomedical degree, Pharmacovigilance case processing experience, Advanced English (C1), Time and issue management skills
Skills
PharmacovigilanceCase managementLife Sciences
About the role
Responsibilities
- Process Individual Case Safety Reports (ICSR) from post-marketing and clinical trial sources
- Manage SAE/SUSAR submissions, unblinding, and clinical trial reconciliations
- Prepare database outputs for periodic reporting such as PBRER, DSUR, and PADER
- Mentor and train junior employees and optimize department procedures
- Ensure compliance with applicable regulations and client-specific requirements
Requirements
- Degree in Life Sciences, Biomedical sciences, or related healthcare field (Chemistry, Biology, Biotechnology, Veterinary Science)
- Demonstrated experience in Pharmacovigilance case processing
- Advanced English skills (C1 level) both verbal and written
- Strong skills in time management, organization, and multitasking
- High attention to detail and strong interpersonal skills
About the Company
PrimeVigilance is a global pharmacovigilance specialist dedicated to patient safety. We help clients navigate complex regulations from early development through post-marketing surveillance, turning safety data into actionable insights.
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Get started — it's freePharmacovigilance Officer
PrimeVigilance · Bucharest
