PrimeVigilance
1 year ago
Senior Pharmacovigilance Physician I
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Company information
- Company
- PrimeVigilance
- Location
- Polska Poland
- Posted
- 1 year ago
Job description
Job Description
- To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding, assessment of seriousness, expectedness, and company causality, as well as writing of company comment, follow-up questions and analysis of similar events. This includes completion of all required supporting documentation such as trackers.
- To support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
- To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
- Reviewing database outputs
Required skills
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