Novartis Pharmacovigilance jobs in india
Safety Writer – Aggregate Reports (AR)
Job Description: 2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluating the benefit-risk profile of the marketed products and collaborating with Health Authorities toward the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety.
Your responsibilities include, but are not limited to:
- Support/lead end-to-end preparation of aggregate safety reports. Support coordination with GLFs to ensure information is received, analyzed, and incorporated into ARs as per the regulatory requirements.
- Retrieve and analyze the safety data from the global safety database and ensure adequate presentation in the ARs.
- Ensure a comprehensive and consistent aggregate analysis is performed to establish the risk-benefit profile of the product that meets all HA requirements.
- Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
- Support independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Novartis standards. Adhere to good documentation practices to ensure audit/inspection readiness.
- Support projects related to operational excellence (including testing of safety systems/IT application) and process improvements according to internal and externals drivers
- Support Health Authority inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings. Responsible to be informed with the current global PV regulatory requirements.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
- Graduate/Post Graduate/Doctorate degree in Life Sciences /Pharmacy/ Medical Sciences or equivalent degree Fluency in English. Knowledge of other languages is desirable.
- 3 to 5 years of experience in drug safety / Development or closely related areas of responsibility
- Preferably, at least 2 years of experience in safety/ medical/scientific/regulatory writing
- Excellent understanding of the drug development process, GCP, and medical terminology
- Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions
- Strong organizational and project management skills, with an ability to lead work groups.
Division: Global Drug Development
Business Unit: CMO & PATIENT SAFETY GDD
Work Location: Hyderabad, AP
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
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