Safety Writing Assistant I

2 months ago

Mumbai, India Fortrea Full time

Perform allied activities such as generation of line listings and summary tabulation, retrieval of data from safety tracking systems, preparation of call for information/contribution, drafting meeting minutes, maintenance of report trackers, mailboxes, etc.

 Compile or support experienced writers in preparations of parts of various safety reports for global regulatory submissions for Labcorp Clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety Update Reports, Risk Management Plans, and other documents as assigned.

 Support Author for individual case narratives or summaries for adverse drug reactions and serious adverse events.

 Support in writing sections of Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.

 Support the creation and update of labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides, and preparation of supporting/justification document.

 Conduct literature searches based on established strategies. Perform a preliminary review of the search outputs to identify information potentially relevant for inclusion in various reports.

 Perform any additional activities, as needed, to meet project requirement, per the manager’s discretion on completion of relevant training.

 Implement the 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.

Fortrea is proud to be an Equal Opportunity Employer:
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