Team Lead - Medical Writer
Neptune Consultants - Mumbai,
Experience in writing PSUR, DSUR, Review of Risk Management Plan. Â
· Write various safety reports (or part of such reports) for global regulatory submissions for clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports Â
· Write Investigator brochures and sections of protocols Â
· Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses Â
· Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process Â
· Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
Ensure compliance of operations with governing regulatory requirements CLICK HERE TO VIEW APPLY
Neptune Consultants - Mumbai,
Experience in writing PSUR, DSUR, Review of Risk Management Plan. Â
· Write various safety reports (or part of such reports) for global regulatory submissions for clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports Â
· Write Investigator brochures and sections of protocols Â
· Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses Â
· Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process Â
· Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
Ensure compliance of operations with governing regulatory requirements CLICK HERE TO VIEW APPLY

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