Full-Time Medical Reviewer I

Responsibilities include: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

Medically qualified as a physician with demonstrated experience in Pharmacovigilance

Any experience in aggregate reports and signal detection is desirable

Excellent interpersonal skills

Ability to plan, organise, prioritise and execute multiple tasks

Ability to work effectively cross culturally and cross functionally and value the importance of teamwork

Communication skills

Presentation skills

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