1. Medical review of valid/non-valid ICSR.
2. Overall assessment of RMP including assessment of important identified and potential risks.
3. To approve/reject selected ICSRs and AOI from literature screening.
4.To request and approve ordering of full text articles and translation. To conduct follow up with author when deemed necessary.
5.Review of literature articles/published studies log, Reference safety information (RSI) or its equivalent, Conclusion of previous periodic reports (if applicable) and Assessment reports previously received from the competent authorities.
6.To collect and document of any new or significant safety information identified during medical/scientific review.

Role: Healthcare & Life Sciences - Other
Industry Type: Clinical Research / Contract Research
Department: Healthcare & Life Sciences
Employment Type: Full Time, Permanent
Role Category: Healthcare & Life Sciences - Other

Education
UG: MBBS in Any Specialization
PG: Medical-MS/MD in Pharmacology

Key Skills
ICSR Valid and nonvalid ICSR Rmp literature screening