For the Client:
- To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
- To act as a Qualified Person for Pharmacovigilance or 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 Safety Update Reports, Development Safety Update Reports, 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
- To cooperate in the preparation of and provide input in Risk Management Plans
- Supporting the preparation of responses to regulatory authority requests
- Signalling
- Reviewing line listings
- Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
- Evaluating and categorizing possible signals and proposing a course of action
- Supporting preparation and review of benefit-risk reports
