Drug Safety Specialist

Drug Safety Specialist

work outline icon5 - 8 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Fidelity Health Services

time outline iconNavi 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.

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