Drug Safety Specialist
Fidelity Health Services
Navi Mumbai, Maharashtra, India
Posted on 03-08-2021
1 Vacancy
Description
- Experience in Pharmacovigilance domain and proficiency in MS-excel
- Management of various safety reconciliation and compliance monitoring activities.
- Review of weekly question logs for key products to identify AE cases.
- Preparation of weekly line listing and data representation for key products.
- Edit, Review and Reconciliation of Consolidated product list- Global.
- Management of Global Exchange of safety information for product approvals / Launches / cancellations and RSI updates - Global.
- Data mining and review of FDA's Adverse Event Reporting System, and other regulatory databases.
- Reconciliation of reference safety information for client products.
- Documentation- Maintaining and updating documents relevant to safety reconciliation.
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Aggregated job.
Learn more