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Location

Mumbai | India

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Job description

Job Description

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 LPcsr

- 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

Job Posting : Mar 04 2024

About Cognizant

Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 185 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at or follow us

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