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About Company

Provide support for medical safety management within the Patient Safety & Pharmacovigilance department, including medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Support the safety lead by creating quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Assist in defining, developing, and implementing metrics, standards, and tools to efficiently oversee the performance of the Pharmacovigilance and Medical Devices Vigilance system regarding medical review of safety cases and management of safety signals.

Position Name :

Medical Safety Expert

Organization :

Novartis

Qualification:

B.Pharm, Bsc, Pharm.D, Ph.D, MBBS, MD

Experience:

2 Years

Salary:

₹6.0 Lakhs to ₹11.1 Lakhs

Location:

India

Major Accountabilities:

  • Provide support for delivery activities, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
  • Perform medical review of ICSRs, including SUSARs, cases from special countries, and assessment of literature cases; author enhanced MAC.
  • Support the safety lead in authoring medical assessment letters based on bi-annual/six-monthly line listings.
  • Perform literature review of assigned articles (CQC, pre-screening, and SICO) and assist the safety lead in reviewing articles for inclusion in PBRER, DSUR, IB, etc.
  • Provide rotating support to the TAs as per business needs, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents.
  • Assist TA Safety Leads in monitoring the safety profile of products, including literature review, medical review of individual cases, collecting additional follow-up information, and medical evaluation of quality defects.
  • Co-author the PBRER with Safety Leads, providing medical inputs to sections 9, 15, 16, 17, and 18, and analytical input for risks defined in the RMP. Perform follow-up activities on HA assessment reports.
  • Contribute to the medical sections of Development Safety Update Report (DSUR), Investigator Brochures (IB), labeling documents (e.g., CDS, SMPC, USPI, Japanese PI), Product Guidance Documents (PGD), and Expert Statements.
  • Support the preparation and review of Investigator Notifications (INs), signal detection, and signal evaluation activities for assigned products.
  • Assist in evaluating and writing safety-related documents, including Clinical Overview, Development Safety Profiling Plan (d-SPP), and RMP.
  • Provide safety input to Addendum to Clinical Overview (ACO) for license renewal and new indication submission.
  • Support the preparation and participation in internal review meetings like SMT, MSRB, and GLC.
  • Act as Subject Matter Expert (SME) for Medical Function processes and provide support during audits and inspections.
  • Collaborate with other Global Line Functions across Novartis and third parties to meet joint accountabilities.
  • Contribute to PV&PV initiatives and cross-functional projects to optimize medical review processes and quality.
  • Develop and optimize training materials and deliver training to Novartis staff and external stakeholders.

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