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Pharmacovigilance Specialist

1-2 years
Not Disclosed
10 June 28, 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

Job Title: Clinical Research Associate (Pharmacovigilance)

Job Overview:

Under moderate supervision, executes feasibility, site identification, regulatory start-up, and maintenance activities at the regional or country level in accordance with regulations, SOPs, and project requirements.

Essential Functions:

  • Execute pharmacovigilance processes applicable to Regional Site Unit (RSU).
  • Submit safety reports (periodic and expedited) in compliance with regulatory timelines.
  • Submit Serious Adverse Events (SAE) / Suspected Unexpected Serious Adverse Reactions (SUSAR) to Regulatory Authorities (RA) as per study requirements.
  • Perform Site Activation (SA) activities at the country level adhering to local and international regulations, SOPs, and project guidelines.
  • Conduct maintenance activities as needed.

Qualifications:

  • Bachelor's Degree in Life Sciences or a related field.
  • 1-2 years of pharmacovigilance experience in clinical studies.
  • Fluent conversational English.

About IQVIA:

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. They are committed to advancing human and data science to foster a healthier world. Learn more at IQVIA Careers.