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Associate Pharmacovigilance Specialist

1-2 years
Not Disclosed
10 March 19, 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
Location: Karnataka, India
Industry: Life Sciences & Healthcare
Work Mode: Hybrid
Job ID: JREQ131105
Posted Date: March 11th, 2025

The Associate Pharmacovigilance Specialist performs pharmacovigilance services such as biomedical literature monitoring and assessment for adverse event reporting, indexing, and abstracting. This role requires broad knowledge of scientific terms, medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

Key Responsibilities:

  • Critically analyze large numbers of articles from biomedical published literature and internal drug safety alerts to identify individual case safety reports (ICSRs) and other safety-relevant information impacting the risk-benefit profile of customer products

  • Write concise narratives summarizing ICSR criteria and other potential safety information in each article

  • Demonstrate understanding of client drug labels and apply that knowledge effectively when performing safety assessments

  • Conduct thorough, accurate, and timely drug safety reviews of each biomedical literature batch in accordance with client standards for timeliness and quality

  • Track all actions and assessments in a drug safety system to maintain an audit-ready reference history

  • Select articles of interest for inclusion in the client's product literature database per established guidelines

  • Write accurate, detailed, and well-organized abstracts of selected articles, ensuring appropriate level of detail, grammar, and syntax

  • Extract key points of articles and create comprehensive and detailed indexes to ensure precise and complete retrieval of literature from client databases

  • Ensure timely completion of indexing and abstracting of articles for assigned drugs to meet regulatory submission deadlines

  • Maintain awareness of new drugs, therapeutic categories, disease entities, and changes in biomedical terminology in the published literature

  • Participate in additional tasks such as searches and terminology maintenance as needed

Experience, Education, Skills, and Accomplishments:

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

  • A degree in Dentistry/Physiotherapy/Nursing, with hospital-based patient exposure, is advantageous

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

  • OR an equivalent combination of education and experience (e.g., an information science degree with at least 1 year of relevant experience in drug and patient safety)

  • Related experience in drug safety/pharmacovigilance is desirable

  • Strong analytical skills to summarize main points of biomedical case reports, studies, or specific topics

  • At least 1 year of experience using writing skills to create succinct, accurate, and precise summaries

  • At least 1 year of working knowledge of biomedical terminology, drugs, and therapeutic areas

  • Excellent English language skills (comprehension, speaking, reading, and writing)

  • Basic computer literacy

Preferred Skills:

  • Certification from a professional medical writer’s association

  • Experience with commercial and client-specific biomedical literature databases

  • Scientific/medical writing background

About the Team:
The PV Literature team supports multiple customers across various therapeutic areas. The team provides a supportive working environment with personalized training and opportunities to engage in different aspects of pharmacovigilance and participate in customer upgrade planning.

Hours of Work:
This is a full-time permanent position working weekdays (Monday to Friday) from 11:00 AM to 8:00 PM IST.

Equal Opportunity:
At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.