Cognizant hiring Aggregate Report Writers

Are you ready to take your career to the next level? Cognizant is seeking a dynamic and experienced Team Manager to join our team in Mumbai, Maharashtra, India. In this role, you will play a crucial role in leading our team of professionals and driving success in our drug safety domain.

TEAM MANAGER

Location: Mumbai, Maharashtra, India

Job ID: 00058033382

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Aggregate Report Scientist:

Job Description:

• Retrieval of previous Periodic Safety Update Report (PSUR) / Developmental Safety Update Report (DSUR), effective Risk Management Plan (RMP), HA request, etc. from client Shared drive.
• Ensure that the latest PSUR/DSUR Template is used for report creation.
• Request input from various stakeholders (including request for affiliates like License Partner [LP] input).
• Review documents/ input received from contributors (including LP).
• Generation of line listing from client safety database using pre-defined criteria or tools.
• Prepare draft PSUR/DSUR, incorporating/ addressing feedbacks/comments from various stakeholders including safety team, clinical team, LP, PSUR Quality Check (QC) team and QPPV (as required).
• Prepare/ compile the final document.
• Peer review of drafted document by other authors ensuring that all client requirements for quality are met; or
• Be part of the separate team to provide independent quality comments on the drafted document and fill necessary checklists documenting the review.
• Get approval for final PSUR/DSUR. Archive PSUR/DSUR in client Shared drive.
• Email to relevant team for initiating publishing of the final report.
• Report activities may be performed in client document management system.
• Update PSUR/DSUR tracker in tracking excel or tool for all Key Performance Indicator (KPIs).
• Any other activity based on client request.
• Training and mentoring of other aggregate reports writers.

Experience:

• Minimum 2-4 years of experience in drug safety domain, of which minimum 2 years of experience in PSUR/DSUR writing.

Qualification:

• B.Pharm/M.Pharm/Ph.D./BDS/BHMS/BAMS/Masters in life science.

Employee Status: Full Time Employee.

Shift: Day Job.

Travel: No.

About Cognizant: Cognizant is a global leader in professional services, dedicated to helping clients transform their businesses for the digital era. With a consultative approach and industry expertise, we enable our clients to innovate and operate more efficiently. Headquartered in the U.S., Cognizant is consistently recognized as one of the most admired companies in the world.

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