Sr PVE/Pharmacovigilance Leader(PVL) - Empirica Triage Team invited in Novartis
Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health.
Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stock Exchange and its wholly owned subsidiaries Novartis Healthcare Private Limited, Sandoz Private Limited and Chiron Behring Vaccines Private Limited.
Post: Sr PVE/Pharmacovigilance Leader(PVL) - Empirica Triage Team
Performs pharmacovigilance activities for all assigned Novartis projects or products including identifying and analyzing safety signals based on a comprehensive evaluation of postmarketing data and Serious Adverse Events (SAEs) from clinical trials.
Major Activities (Describe main activities)
1. Monitors the clinical safety signals of assigned projects/products in the Empirica Tool and available Health Authority databases .
2. Performs medical evaluation and assessment for signals of assigned products in Empirica, including collecting additional follow-up information as necessary, , review of line listings of single cases, aggregate reports and other information that may be relevant for the initial medical assessment of a signal (e.g. literature)
3. Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools.
4. Provides input into responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues.
5. Prepares medical input to aggregate clinical safety regulatory reports (including RMPs) as needed.
6. Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Novartis drugs.
7. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
8. Participates in review of clinical study protocols/reports/other regulatory documents as needed.
9. Works closely with the BSL for the assigned products and provides relevant input for SMT meetings as needed.
10. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
Ideal BackgroundEducation (minimum/desirable): Medical Degree or Pharm.D Specialty Board certification desirable.
Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
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