Medical Reviewer I

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 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

To review and provide input in Periodic Safety Update Reports

To review and provide input in Development Safety Update Reports

Participating in signal detection activities including meetings and writing signal detection reports

Proposing a course of action whenever a possible signal is identified

For the Company (This may include but is not limited to):

Writing PV Procedures

Mentoring less experienced Physicians