Full-Time Medical Reviewer I

Responsibilities:

• Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment.
• Review includes coding, assessment of seriousness, listedness/expectedness and company causality.
• Write company comment, follow-up questions and analysis of similar events.
• Complete required supporting documentation such as trackers.
• Review literature screening search strategy and articles to determine if they contain ICSRs/SAEs.
• Review database outputs.
• Review and provide input in Periodic Safety Update Reports and Development Safety Update Reports.
• Participate in signal detection activities, including meetings and writing signal detection reports.
• Propose a course of action whenever a possible signal is identified.
• Write PV Procedures.
• Mentor less experienced Physicians.

Requirements:

• Medically qualified as a physician with demonstrated experience in Pharmacovigilance.
• 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.
• Communication skills & Presentation skills.

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