Medical Reviewer @ Golden Opportunities

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Medical Reviewer

Golden Opportunities
2 - 4 Years
Chennai
4 years ago
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Job Description

Job Description :

Diligent evaluation and assessment of complex reports from clinical development projects as well as post marketing cases.
Reporting sources include medical literature as well as from post marketing surveillance studies. He/ she must ensure high medical quality and compliance with all health authority requirements regarding AE/ADR single case handling.
Ensure medical plausibility consistency and completeness of SADR case reports.
Request follow-up information and initiate use of specific product/event-related questionnaires when necessary.
Confirm determination of seriousness assess drug product causal association and assign global labeling status (expected or unexpected) in order to achieve the appropriate case reporting status for global distribution for regulatory agency reporting.
Medical coding of various case data including all AE and Drug terms. This requires in depth knowledge of the present coding systems (MedDRA and WHO-DD) with respect to structure and medical content. Create written company causality comment for ADR case reports in accordance with internal standards and guidelines.
Review case source documents and queries.
Confirm accuracy and appropriateness of medical coding seriousness and expectedness.
Provide SAE causality for product complaints and safety device evaluation.
MCI certification is a must

Employement Category:

Employement Type: Full time
Industry: Pharmaceutical
Functional Area: Pharmaceutical
Role Category: Medical Affairs Manager
Role/Responsibilies: Medical Reviewer

Contact Details:

Company: Golden Opportunities
Location(s): Chennai

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Medical Reviewer @ Golden Opportunities

Home > Medical Affairs Manager