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Associate Pharmacovigilance Specialist

1-2 years
Not Disclosed
10 March 9, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Associate Pharmacovigilance Specialist

Location: Karnataka, India

Job Type: Hybrid | Full-Time

Job Overview:

The Associate Pharmacovigilance Specialist is responsible for monitoring biomedical literature for adverse event reporting, indexing, and abstracting. This role requires a strong understanding of scientific terminology, pharmacovigilance regulations, drugs, and therapeutic areas to ensure accurate reporting of safety-relevant information.

Key Responsibilities:

  • Review and analyze biomedical literature and internal drug safety alerts for individual case safety reports (ICSRs) and other potential safety-relevant information.
  • Summarize ICSR criteria and safety-related findings in brief narratives.
  • Apply knowledge of drug labels and safety profiles in assessing biomedical literature.
  • Ensure accuracy and compliance with regulatory requirements and standard operating procedures.
  • Track actions and assessments in the drug safety system for audit-ready documentation.
  • Select relevant articles for inclusion in the client’s product literature database.
  • Write detailed abstracts and indexes for selected articles, ensuring completeness and precision.
  • Stay updated on new drugs, therapeutic categories, and biomedical terminology.
  • Participate in searches, terminology maintenance, and other pharmacovigilance duties as required.

Qualifications & Experience:

  • Master’s degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
  • A Dentistry, Physiotherapy, or Nursing degree with hospital-based patient exposure is an advantage.
  • 1-2 years of experience in biomedical literature review for adverse event reporting.
  • Strong analytical and writing skills to summarize complex biomedical case reports.
  • Working knowledge of biomedical terminology, drugs, and therapeutic areas.
  • Experience with commercial and client-specific biomedical literature databases.
  • Excellent English language skills (reading, writing, speaking, and comprehension).

Preferred Qualifications:

  • Certification from a professional medical writing association.
  • Experience in scientific/medical writing.

Work Schedule:

  • Full-time, permanent role (Monday to Friday, 11:00 AM – 8:00 PM IST).

Why Join Us?

  • Opportunity to work in a collaborative and supportive environment.
  • Exposure to multiple therapeutic areas and pharmacovigilance operations.
  • Personalized training and career development opportunities.