Spec I Pss - Navi Mumbai, India - Labcorp
Description
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
Create, maintain and assume accountability for a culture of high customer service
Write various safety reports (or part of such reports) for global regulatory submissions for Labcorp's clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports
Write Investigator brochures and sections of protocols
Write Clinical Study Reports (in whole or in part) for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses
Assist pharmacovigilance teams in writing narratives for the adverse drug reactions and adverse events they process
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.
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