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
Qualification: MBBS / MD
Experience: 0-1 yr
Contact Person: Lohitha
Contact Number: 6383069903
Mumbai, Pune, Bangalore/Bengaluru