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Team Lead

4 months ago

Mumbai, Maharashtra, India Cognizant Full time

Aggregate report scientist:

Job description:

Create, update, and finalize necessary template and final reports in Document Management System with the relevant approvers and e-signer in the DMS.

Identify relevant stakeholders, hold strategy call with line functions and manage round table reviews with stakeholders

Manage internal / external communications required to provide high quality draft of reports

Request input from various stakeholders (including request for License Partner [LP] input)

Review documents/ input received from contributors (including LP). Identify and take action to obtain pending inputs whenever there is an issue in terms of pending inputs and archive all inputs/communications accordingly

Retrieval of relevant documents including Periodic Safety Update Report (PSUR) / Periodic Benefit Risk Evaluation Report (PBRER)/Development Safety Update Report (DSUR), effective Risk Management Plan (RMP), HA request etc. from client Shared drive, if required.

Generation of line listing from client safety database or request listings from relevant team based on specific inputs taken from safety lead

Ensure overall quality, draft document consistency (i.e. between different sections/annexes of the aggregate report/RMP/B-R report and with reference source documents, e.g., labelling document, clinical and non-clinical study report, SCS, CO, statistical outputs, literature documents, response documents, PSUR/DSUR and other documents as required) during preparation

Incorporating/ addressing feedbacks/comments from various stakeholders including safety team, LP, Quality Check (QC) team and QPPV (as required)

Peer review of drafted document by other authors ensuring that all client requirements for quality are met

Prepare/ compile the final document

Upload final report in client Document Management System for approval.

Also archive all source data for the report in document management system or client Shared drive, including all draft and reviewed versions.

Ensure client approval on the final report

Email to relevant team for initiating publishing of the final report in client Document Management System

Update report tracker with all Key Performance Indicator (KPIs)

Any other activity based on client request

Competencies:

Good negotiation, project management and communication skills.

Experience in managing global, cross-functional teams or simple global projects will be desirable.

Experience:

Minimum 5-6 years of experience in Pharmacovigilance; of this

Minimum 3 years of experience in aggregate report writing (PSUR, DSUR or AdCO). Previous experience in DSUR preferred.

Qualification:

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