Spec I Pss - Navi Mumbai, India - Labcorp

Labcorp
Labcorp
Verified Company
Navi Mumbai, India

2 weeks ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter


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


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