Pharmacovigilance Specialist
Location: Karnataka, India
Industry: Life Sciences & Healthcare
Work Mode: Hybrid
Job ID: JREQ131113
Posted Date: March 11th, 2025
The Pharmacovigilance Specialist performs pharmacovigilance services such as biomedical literature monitoring and assessment for adverse event reporting, indexing, and abstracting. This role requires extensive 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 4 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 4 years 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
Experience in indexing abstracts from literature and providing feedback to primary screeners who fail to report adverse events
At least 4 years of experience using writing skills to create succinct, accurate, and precise summaries
At least 4 years of working knowledge of biomedical terminology, drugs, and therapeutic areas
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.
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