Sr Pharmacovigilance Expert Empirica
Novartis Healthcare Pvt. Ltd.
1 - 5 yrs
Hyderabad / Secunderabad
Job Description
- Provide support to the Brand Safety Leader/ Pharmacovigilance Leader (BSL/ PVL) in the monitor-ing of the safety profile of assigned products including: Periodic Safety Update Report (PSUR), Risk Management Plan (RMP) updates and associated activities, safety signal detection, coordinat-ing the management of large datasets for analysis purposes , responses to external authorities, review of clinical protocols and other regulatory activities, and responsibility for the clinical review and evaluation of cases including input for follow-up and data cleaning, within agreed timeframes and to a high standard of accuracy, in compliance with IMS business rules, standard operating procedures and global and local regulatory requirements 1. Assist the BSL/ PVL in monitoring the safety profile of product 2. Provide input into responses to inquiries from regulatory authorities or health care profes-sionals on safety issues 3. Provide input to responses for CPO requests involving safety issues 4. Assist in the development and updates concerning safety input to the core data sheet and the investigators brochure 5. Play an active role in standing and ad hoc Safety Management Team (SMT) meetings 6. Play an active role in SIGDET and MSRB meetings including preparatory activities 7. Assist with project activities on an ad hoc basis 8. Interfaces with the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events, updating on PVO
Manage daily operation and complete the task as per require TAT.
Company Profile:
Novartis Healthcare Pvt. Ltd.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
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