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Associate Pharmacovigilance Specialist

1-2 years
Not Disclosed
10 March 6, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Associate Pharmacovigilance Specialist

Company: Clarivate
Location: Karnataka, India (Hybrid)
Job ID: JREQ131104
Job Type: Full-Time, Permanent
Posted Date: March 3, 2025

Job Responsibilities:

  • Monitor biomedical literature to identify adverse event reports and safety-relevant information.
  • Write brief narratives summarizing individual case safety reports (ICSRs).
  • Analyze biomedical articles and internal drug safety alerts to assess potential risk-benefit and safety profiles.
  • Ensure timely and accurate drug safety reviews in accordance with client standards.
  • Track all assessments and actions in a drug safety system for audit readiness.
  • Select and index relevant articles for client-specific product literature databases.
  • Write detailed abstracts with proper grammar, syntax, and organization.
  • Maintain awareness of new drugs, therapeutic categories, and biomedical terminology.
  • Participate in additional tasks such as searches and terminology maintenance as required.

Qualifications & Skills:

  • Education:
    • Master’s Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
    • Degrees in Dentistry, Physiotherapy, or Nursing (with hospital-based patient exposure) are an advantage.
  • Experience:
    • 1-2 years of experience reviewing biomedical literature for adverse event reporting.
    • Related experience in drug safety/pharmacovigilance is desirable.
    • At least 1 year of writing experience for accurate summaries.
    • Knowledge of biomedical terminology, drugs, and therapeutic areas.
    • Experience with commercial and client-specific biomedical literature databases is a plus.
  • Skills:
    • Strong analytical skills to assess case reports and studies.
    • Excellent English language skills (reading, writing, speaking, comprehension).
    • Basic computer literacy and ability to work with drug safety systems.
    • Certification from a professional medical writing association is preferred.

Work Hours:

  • Monday to Friday
  • 11 AM - 8 PM IST

About the Team:

The Pharmacovigilance Literature Team supports multiple clients across therapeutic areas. It offers a collaborative work environment, personalized training, and opportunities to engage in broader pharmacovigilance roles.