Full-Time Medical Reviewer I

• 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.

• 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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