Pharmacovigilance Physician II

For our clients, 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, listedness/expectedness and company causality, as well as writing of company comments, follow-up questions and analysis of similar events, when required, including the 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 and provide input in periodic reports. The PV Physician will support the Project Manager, as well as the QPPV, on a day to day basis as needed.