Role & Responsibilities
• Prepare and quality-check aggregate reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), and US Periodic Adverse Drug Experience Reports (PADERs) from aggregate data
• Conduct signal detection-related analyses, including cumulative analyses, issue event analyses, and Signal Evaluation Reports
• Review published literature and case listings, ensuring vigilance over important/designated medical events
• Interact with client personnel to discuss potential signals and issues detected with products
• Support the preparation and maintenance of Risk Management Plans (RMPs)
• Follow-up with clients to obtain missing or incomplete information to resolve and clarify issues
• Perform medical review of individual case safety reports (ICSRs) and narratives for Clinical Study Reports (CSRs)
• Provide medical advice to drug safety scientists on the processing of ICSRs and CSR narratives
• Maintain knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines
• Ensure compliance with global regulatory reporting obligations and internal timelines for report submissions
• Maintain records in compliance with guidelines and Standard Operating Procedures (SOPs)
Qualification
• A degree in Medicine (MBBS) or a post-graduation qualification (MD), preferably in a clinical branch
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Strong ability to evaluate and interpret data, synthesize scientific information, and write concise and accurate medical text
Experience
• Experience in drug safety, pharmacovigilance, or regulatory reporting is preferred
• Fluency in written and spoken English
• Ability to work with web-based applications and proficiency in computer skills in Windows 10/Windows 7
Skills
• Ability to make concise, accurate, and relevant synopses of medical text and data
• Attention to detail and strong analytical skills
• Typing and transcription accuracy
About The Company
• Continuum India – A leading contract research organization (CRO) trusted by global leaders in the pharmaceutical and healthcare industries. Continuum India specializes in providing comprehensive services in the domains of pharmacovigilance, regulatory affairs, evidence evaluation, and technology solutions.
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