- The designated person will be responsible for leading the Pharmacovigilance activities in India, Bangladesh, Nepal and Sri Lanka as per regulations defined in the country. Case management and expediting the periodic reporting as per country regulations.
- Driving the related pharmacovigilance compliance with in the India affiliate.
- Coordinating with third parties for the safety agreements and related compliance.
- Required case entries and coordination with regional hub for getting related safety information and reportings.
- Ensuring the affiliate persons and sales teams are well trained on safety reporting.
- Monitor local changes in safety regulations.
- Maintenance of clinical trials and related safety reporting for Lilly clinical studies including post marketing studies as per local regulations. Coordination with designated CROs and sites for the studies and related safety reporting.
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