Senior Pharmacovigilance Expert
Novartis Healthcare Pvt. Ltd.
3 - 7 yrs
Job Description
- Provide support to the Brand Safety Leader/Pharmacovigilance Leader (BSL/Sr BSL) in monitoring the safety profile of assigned products by providing quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with IMS business rules, standard operating procedures and global and local regulatory requirements 1.Performs single case medical review in the safety database or on line listings. Writes investigator notifications and ethics committee medical statements. Medical review of single case reports will be performed by associates possessing medical degree. 2.Performs signal triage and detection activities. 3.Authors parts of the medical sections of complex PSURs, DSURs and RMPs (requiring minimal supervision from PVL/BSL) and/or has full authorship of the above for less complex products. 4.Acts as a deputy for existing PVLs assuming full responsibility during the deputization period. 5.Contributes to the development and updates of safety sections of Core Data Sheets and associated documents such as clinical overview 6.Provides DSE input into clinical and DRA deliverables including study protocols, clinical study reports, clinical submission documents and Investigators Brochure as needed. 7.Plays an active role in Safety Management Team (SMT) meetings and may deputize for the PVL. 8.Chairs the Safety Processing Team (SPT). 9.Plays an active role presentation to SIGDET meetings including preparatory activities. 10. Interfaces with clinical teams for safety matters including follow-up on SAEs of interest (e.g. input into site queries), update on PVO requirements. 11. Provides support as required for licensing activities, regulatory authority inspections/audits and for project/product recall activities. 12. Mentors newly recruited colleagues by supporting their integration into the PVE role.
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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