Roles & Responsibilities:
• Perform medical review and clarification of trial-related adverse events (AEs) and post-marketing adverse drug reactions (ADRs), including narratives, coding, expectedness, seriousness, causality, and summaries.
• Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as per regulatory requirements.
• Review coding of AEs, SAEs, SADRs, past medical history, concomitant medications, and other clinical data listings.
• Serve as an internal consultant to pharmacovigilance case processing teams on assigned projects.
• Perform medical safety review of protocols, Investigator Brochures, and Case Report Forms (CRFs) for safety content and data capture.
• Provide aggregate reviews of safety information, including clinical data, post-marketing data, literature, and observational studies (e.g., DSUR, RMP, PBRER, ad hoc reports).
• Lead and participate in training, product transitions, audit preparation, and knowledge exchange initiatives.
• Review and approve Project Safety Plans and Medical Monitoring Plans per agreed medical safety scope.
• Attend project and medical safety team meetings, representing safety and clinical data review findings to clients.
• Act as Lead Safety Physician or provide backup support on assigned projects, including 24-hour medical support when required.
• Support signal detection efforts and provide medical escalation support for regulatory and safety queries.
Qualification:
• Medical degree from an accredited and internationally recognized medical school.
• Valid medical license or equivalent preferred.
Experience:
• Minimum 3 years of clinical practice experience post-medical degree.
• Minimum 2 years of experience in the pharmaceutical industry preferred, or equivalent combination of clinical and pharma experience.
• Knowledge of GCP, ICH guidelines, pharmacovigilance processes (ICSRs and aggregate reports), and departmental SOPs.
Skills:
• Strong medical knowledge and ability to evaluate safety data.
• Experience with multiple safety databases and Microsoft Office (Word, Excel, PowerPoint).
• Excellent verbal and written communication skills.
• Ability to build and maintain effective working relationships with colleagues, clients, regulatory agencies, and study sites.
About the Organisation:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. The company leverages data, technology, and advanced analytics to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.
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