Full-Time Medical Reviewer I

Medical Reviewer I is responsible for medical review of lCSRs and literature review, writing of signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS/PBRERs/PADERS) as required by the Company or Client.

Responsibilities include:

• 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.
• Review literature screening search strategy
• Review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
• Reviewing database outputs
• Review and provide input in Periodic Safety Update Reports
• 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

Qualifications:

• Medically qualified as a physician with demonstrated experience in Pharmacovigilance
• Any experience in aggregate reports and signal detection is desirable

Skills:

• Excellent interpersonal skills
• Ability to plan, organize, prioritize 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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