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Associate Pharmacovigilance Specialist

1-2 years
Not Disclosed
10 March 18, 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 - Clarivate

Location: Karnataka, India
Job Type: Full-time, On-site
Posted: 6 days ago
Application Status: Over 100 people clicked apply


About the Job:

The Associate Pharmacovigilance Specialist performs pharmacovigilance services such as biomedical literature monitoring and adverse event reporting. Responsibilities include indexing, abstracting, and ensuring compliance with pharmacovigilance regulations through a strong understanding of scientific terms, medical terminology, and therapeutic areas.


Experience, Education, Skills, and Accomplishments:

  • Education:

    • Master’s Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).

    • A degree in Dentistry, Physiotherapy, or Nursing with patient exposure in a hospital-based environment is advantageous.

  • Experience:

    • 1-2 years of experience reviewing biomedical literature for adverse event reporting.

    • Related experience in drug safety/pharmacovigilance is desirable.

    • Strong analytical skills to analyze and summarize biomedical case reports or topics.

    • At least 1 year of experience with writing skills to create precise and succinct summaries.

    • Working knowledge of biomedical terminology, drugs, and therapeutic areas.

    • Basic computer literacy.

Preferred:

  • Certification from a professional medical writer’s association.

  • Experience with commercial and client-specific biomedical literature databases.

  • Background in scientific/medical writing.


Key Responsibilities:

  • Analyze large volumes of biomedical literature and internal drug safety alerts to identify individual case safety reports (ICSRs) and safety-relevant information.

  • Summarize ICSR criteria and other safety information accurately.

  • Apply knowledge of client’s drug labels during safety assessments.

  • Ensure timely, accurate, and high-quality drug safety reviews of biomedical literature batches.

  • Use drug safety systems to track actions and assessments in an audit-ready reference history.

  • Select relevant articles for inclusion in client’s product literature database following guidelines.

  • Write accurate, detailed abstracts and create comprehensive indexes for article retrieval.

  • Complete indexing and abstracting tasks within regulatory submission deadlines.

  • Stay updated on new drugs, therapeutic categories, and changes in biomedical terminology.

  • Perform other duties such as literature searches and terminology maintenance as required.


About the Team:

The PV Literature team supports multiple customers across all therapeutic areas, offering a supportive work environment with personalized training and opportunities to engage in different aspects of pharmacovigilance.


Work Hours:

  • Full-time permanent position

  • Workdays: Monday to Friday

  • Working Hours: 11 AM - 8 PM IST


About Clarivate:
Clarivate is committed to providing equal employment opportunities to all individuals in compliance with applicable laws and regulations.