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Drug Safety Specialist

Fidelity Health Service
Fidelity Health Service
3-4 years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: B. Pharm / M. Pharm/ BAMS/ BHMS 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

Drug Safety Specialist

Location: Mumbai, Pune (India)
Qualification: B. Pharm / M. Pharm / BAMS / BHMS
Experience:

  • Minimum 3-4 years of experience in case processing/safety writing and knowledge of SDEA management.
  • Experience in exchanging safety data/conducting reconciliations with business partners.
  • Strong written and verbal communication/presentation skills.
  • Up-to-date with the latest technical/scientific developments related to Pharmacovigilance (PV).

Job Responsibilities:

  • Initiate communications with internal stakeholders like business teams and subsidiaries to understand the requirements of SDEAs (Safety Data Exchange Agreements).
  • Follow up with third parties/business partners for ensuring SDEAs are in place.
  • Timely exchange of safety data with partners and conduct adverse event reconciliation with them.