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Medical Reviewer
ConfidentialIndore8 days ago
Job descriptionAuthor and edit clinical and periodic report comments in the Patient Safety database. Review medical sense of cases, including seriousness, coding, and associated clinical information. Provide detailed follow-up information and case updates as required. Respond to queries from the Case Owner and detail requests for case changes. Offer product-specific advice, particularly for SUSAR cases. Document reviews and case comments in the Medical Review workflow (Sapphire). Ensure adherence to global and local procedural documents and policies. Extensive medical knowledge with the ability to critically assess clinical data. Attention to detail, analytical thinking, and strong communication skills. Bachelor of Statistics, Bachelor of Technology, MBBS, MD, or MS.
Role Overview
- Assess and handle clinical data and case reports, particularly Suspected Unexpected Serious Adverse Reactions (SUSAR).
- Ensure compliance with global and local procedural documents while maintaining up-to-date knowledge of marketed drugs under litigation.
Key Responsibilities
Clinical Data Review
Query Management
Documentation and Compliance
Desired Skills
Qualifications
Skills Required
medical review , Pharmacovigilance, clinical data analysis , Case Management
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Medical Medical • Indore
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