Associate Pharmacovigilance Specialist
About the Role
Roles & Responsibilities
• Review and analyze large volumes of biomedical literature and internal drug safety alerts
• Identify Individual Case Safety Reports (ICSRs) and other safety-relevant information as per regulatory requirements
• Assess adverse events for reporting, indexing, and abstracting
• Write concise narratives summarizing ICSR criteria and safety-related findings
• Evaluate safety information impacting the risk-benefit profile of client products
• Apply knowledge of drug labels during safety assessments
• Complete literature review batches within defined timelines and quality standards
• Use drug safety databases/systems to document actions in an audit-ready manner
• Ensure compliance with pharmacovigilance regulations, SOPs, and company policies
Qualification
• Master’s Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.)
Experience
• Fresher or up to 2 years of experience in biomedical literature review for adverse event reporting
• OR equivalent combination of education and relevant experience (e.g., Information Science degree with 1+ year in drug safety support)
Skills
• Strong analytical ability to interpret and summarize biomedical case reports and studies
• Working knowledge of biomedical terminology, drugs, and therapeutic areas
• Familiarity with commercial and client-specific biomedical literature databases
• Effective time management skills
• Excellent written and verbal English communication
• High motivation with ability to work in a fast-paced environment
• Strong adherence to SOPs and regulatory guidelines
About the Company
Clarivate provides pharmacovigilance and drug safety services to global clients across multiple therapeutic areas. The organization offers a supportive work environment with structured training and opportunities to gain exposure to diverse aspects of pharmacovigilance and client engagement.
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