PV Physician II

For the Client (may include but is not limited to the following):

• 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, listedness/expectedness and Company causality, as well as writing of Company comment, follow-up questions and Analysis of Similar Events, when required. Including 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
• To review literature screening search strategy
• To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• Reviewing database outputs
• Can be delegated to support signal detection activities upon acquiring sufficient experience
• Proposing a course of action whenever a new risk is identified