Posted 7 hours ago
Pharmacovigilance Officer
PrimeVigilance
Requirements
Life science or biomedical degree, Pharmacovigilance case processing experience, Advanced English (C1), Time and issue management skills
Skills
PharmacovigilanceLife 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
