Executive / Sr. Executive - Drug Safety Specialist

5-8 years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: B Pharm / M Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

Executive / Sr. Executive - Drug Safety Specialist

Location: Navi Mumbai
Qualification: B Pharm / M Pharm
Experience: 5-8 years in Pharmacovigilance domain
Job Profile: Reconciliation and Compliance Monitoring Activities

Job Responsibilities:

  • Management of various safety reconciliation and compliance monitoring activities for clients.
  • Reconciliation of reference safety information for client’s products.
  • 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.
  • Management of global exchange of safety information for product approvals, launches, cancellations, and RSI updates globally.
  • Maintaining and updating documents relevant to safety reconciliation.