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Executive / Sr. Executive - Drug Safety Specialist

5-8 years
Not Disclosed
10 Aug. 2, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Pharmacovigilance Specialist - Reconciliation & Compliance

Qualifications:

  • B. Pharm / M. Pharm

Location: Navi Mumbai

Experience:

  • 5-8 years in the pharmacovigilance domain.
  • Proficiency in MS Excel and mailbox management.

Job Responsibilities:

  • Oversee safety reconciliation and compliance monitoring activities for clients.
  • Reconcile reference safety information for client products.
  • Conduct data mining and review of FDA's Adverse Event Reporting System (FAERS) and other regulatory databases.
  • Edit, review, and reconcile the Consolidated Global Product List.
  • Manage the global exchange of safety information related to product approvals, launches, cancellations, and RSI updates.
  • Maintain and update documents relevant to safety reconciliation.

How to Apply:

  • Send your CV to hr@fidelityhs.com.