Pharmacovigilance Expert
Novartis Healthcare Pvt. Ltd.
4 - 7 yrs
Hyderabad / Secunderabad
Job Description
- Provide support to the Brand Safety Leader/ Pharmacovigilance Leader (PVL/ 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. Assist the BSL/ PVL in monitoring the safety profile of products potentially including activities such as literature review, evaluation of individual cases or signal detection. Medical review of single case reports will be performed by associates possessing medical degree.
2. Together with the BSL/ PVL, co- author the PSUR including analytical input to PSUR for known and potential risks defined in the RMP.
3. Together With BSL/ PVL, assist in the development, maintenance and implementation of the RMP including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures
4. Assist in evaluating and writing other safety deliverables including but not limited to clinical overviews, ad hoc health authority queries, drug safety product profile (DSPP) , drug safety update report (DSUR)
5. Assist in providing safety input to DRA and clinical documents (e. g. core data sheet and investigator brochure)
6. Play an active role in standing and ad hoc Safety Management Team (SMT) and Safety Project Team (SPT) meetings
7. Play an active role in SIGDET and MSRB meetings including preparatory activities
8. Interface 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 requirements
9. Quality of work delivered (attention to details, thoroughness, medical sound judgment,writing)
10. Timeliness of deliverables according to established directives
11. Compliance with Internal and external regulations and procedures
12. High level of independence
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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