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Pharmacovigilance Specialist

4+ years
Not Disclosed
10 March 9, 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

Job Title: Pharmacovigilance Specialist

Location: Karnataka, India (Hybrid)

Job Overview:

The Pharmacovigilance Specialist is responsible for biomedical literature monitoring, adverse event assessment, indexing, and abstracting using expertise in scientific terminology, pharmacovigilance regulations, and therapeutic areas.

Key Responsibilities:

  • Analyze biomedical literature to identify individual case safety reports (ICSRs) and safety-related information.
  • Summarize ICSR findings in concise narratives following regulatory requirements.
  • Review drug safety alerts and ensure accuracy in reporting.
  • Track actions in a drug safety system for audit readiness.
  • Select relevant articles for client product literature databases per guidelines.
  • Write detailed abstracts and index key points to facilitate literature retrieval.
  • Stay updated on new drugs, therapeutic areas, and biomedical terminology.
  • Participate in additional pharmacovigilance-related duties as required.

Qualifications & Experience:

  • Master’s degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
  • Degree in Dentistry, Physiotherapy, or Nursing with hospital-based experience is an advantage.
  • Minimum 4 years of experience in biomedical literature review for adverse event reporting OR equivalent experience in drug and patient safety.
  • Strong analytical and writing skills for creating precise summaries and indexes.
  • Experience in abstract indexing and providing feedback to primary screeners.

Preferred Skills:

  • Certification from a professional medical writer’s association.
  • Experience with biomedical literature databases.
  • Scientific/medical writing background.

Work Schedule:

  • Full-time, permanent position (Monday to Friday)
  • Shift Timing: 11 AM - 8 PM IST