
Comprehensive Medical Reviewer
7 days ago
As a Medical Reviewer, you will be responsible for the comprehensive medical review of individual case safety reports (ICSRs) and ensuring compliance with regulatory and client-specific requirements.
Perform medical review of ICSRs for accuracy, medical relevance, and consistency with the source documents and safety database entries, in alignment with client requirements. Suspect product coding Event selection and MedDRA coding (current version)
Event coding and classification Perform comprehensive medical evaluation of adverse event reports including serious/expedited cases and pregnancy-related reports. Assess adverse events for seriousness, listedness, and causality, ensuring all medically relevant data from source documents is accurately reflected.Provide or verify company pharmacovigilance (PV) comments as needed. Initiate appropriate follow-up queries based on the clinical context of the case. Ensure completeness and medical soundness of cases before providing final medical sign-off. Participate in literature surveillance and aggregate report medical review, ensuring compliance with regulatory timelines and SOPs.
Key Skills:
- High attention to detail
- Sound medical judgment
- Proficiency in medical terminology, disease pathology, pharmacology, and therapeutics
- Ability to analyze and interpret adverse event data
- Good comprehension and the ability to summarize complex medical data
- Familiarity with pharmaceutical industry practices and drug development processes
Requirements:
• MBBS and MD degrees (non-negotiable)
• Medical Council of India registration (Mandatory)
What We Offer:
We are proud to be an equal employment employer and committed to the culture of inclusion and diversity. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
This is a unique opportunity to work in a dynamic and innovative environment, where you can grow your skills and career while making a meaningful impact in the healthcare industry.
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