Cognizant Hiring Team Lead – Aggregate Reporting (Pharmacovigilance) Role

Cognizant Hiring Team Lead – Aggregate Reporting (Pharmacovigilance) Role

21 March, 2022

About the job

Reporting To – Team Manager



Minimum Educational Qualification- B.Pharm / M.Pharm / PhD / BDS /BHMS /BAMS/ Masters

in Life Sciences.

Preferred Working Experience- 4-5 years of experience in drug safety / development or

closely related areas of responsibility or 2 years of working experience in aggregate report

writing. Experience of safety document writing desirable. Experience of Periodic Adverse Drug

Experience Report (PADER) authoring

Essential Skills

  • Relationship building ability
  • Interface within team members and with other departments
  • Personal grooming and etiquette
  • Inclination towards being process driven
  • Going out of the way to satisfy the external customer
  • Self-motivation
  • Achievement orientation
  • Inter personal effectiveness
  • Language Competencies: Fluency in English. Knowledge of other languages




  • Retrieval of previous Periodic Safety Update Report (PSUR) / Periodic Benefit Risk

Evaluation Report (PBRER), effective Risk Management Plan (RMP), HA request

etc. from Novartis Shared drive

  • PBRER Template creation in Novartis document management system.
  • Request input from various stakeholders (including request for License Partner [LP]

input) for Legacy Pharma PBRERs

  • Review documents/ input received from Novartis (NVS) contributors (including LP)
  • Coordinate with Novartis DS&A regarding generation of line listing
  • Coordinate with PSUR coordinator(s) in case line listings are not accessible.
  • Prepare draft aggregate report, Incorporating/ addressing feedbacks/comments

from NVS stakeholders including safety team, LP and NVS PSUR Quality Check

(QC) team

  • Prepare/ compile the final document
  • Upload final PBRER in Novartis Document Management System for Therapeutic

Area Safety Leader (TASL) approval. Archive PBRER in Novartis Shared drive.

  • Email to PBRER mail-box for initiating publishing of the final report in Novartis

Document Management System

  • Update PBRER tracker in Novartis Shared drive for all Key Performance Indicators


Employee Status : Full Time Employee

Shift : Day Job

Travel : No

Job Posting : Mar 17 2022

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 @Cognizant.


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