Cognizant Pharmacovigilance Drug Safety team lead openings at Hyderabad

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Cognizant Hiring Pharmacovigilance Drug safety Team Lead Job Openings at Hyderabad Location


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


Achievement orientation

Inter personal effectiveness

Language Competencies: Fluency in English.

Knowledge of other languages

desirable Operational


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 (KPIs)

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