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
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
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 (KPIs)
To apply for this job please visit careers.cognizant.com.