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Pharmacovigilance Scientist

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Subject Matter Expert Contribute to DS&E projects 1.Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents.2.Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety re- ports (Periodic Safety Update Reports, US Periodic Reports) for Novartis mature portfolio collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures. 3.Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).4.Review global marketing programs and establish process for AEs collection with global marketing teams. 5.Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments.6.Collaborate with Electronic Data Management team to reconcile Serious Adverse Events be- tween the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database. 7.Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.8.Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and database, authoring or contributing to Product Specific Guidelines for assigned products. 9.Contribute to the preparation of Standard Operating Procedures and Argus processing conventions (MAP).10. Support the development and testing of safety systems/IT applications and in the preparation of relevant manuals. 11. Support Health Authorities inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings.12. Train and mentor new DS&E associates. 13. Number, timeliness and quality of deliverables according to established directives.14. Ability to learn quickly 15. Consistent demonstration of company values & behavior.
Degree: M.Pharm. (Pharmacy) | MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 3-5


Clinical Research | Data Management/ Statistics | Quality Assurance/ Control | Research Scientist
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