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Drug Safety Specialist

Fidelity Health Service
Fidelity Health Service
3-4 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

Share CV on hr@fidelityhs.com
 

Job Opportunity: Pharmacovigilance Specialist

Qualifications:

  • B. Pharm / M. Pharm / BAMS / BHMS

Locations: Mumbai, Pune (India)

Experience:

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

Job Responsibilities:

  • Initiate and manage communications with internal stakeholders, including business teams and subsidiaries, to understand SDEA requirements.
  • Follow up with third parties/business partners to ensure SDEAs are established.
  • Timely exchange of safety data with partners and conduct adverse event reconciliation with partners.