Job Description
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.
About PrimeVigilance
PrimeVigilance, part of Ergomed PLC, is a specialized mid-size pharmacovigilance service provider established in 2008, offering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.