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 deliverablesEnsure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service
Efficiency in conducting literature searches for authoring various types of reports
Author/review 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, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents as assigned.
Author/ review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
Perform allied activities like:
Generation of line listings and summary tabulation, CFIs CFCs
Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting/justification document
Author/review SOPs/WIs/process documents or sections as applicable
Impart/conduct Trainings for peers and team members
Any additional activities as per the project requirement or manager's discretion on completion of relevant trainings
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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