Safety & Pharmacovigilance Specialist I – Literature Review
Company: Syneos Health
Location: Pune, Maharashtra, India
Job Type: Full-Time
Experience Required: 2–4 Years
Job ID: 25104540
Last Updated: December 23, 2025
Job Overview
Syneos Health is hiring a Safety & Pharmacovigilance (PV) Specialist I – Literature Review to support end-to-end drug safety activities, including literature surveillance, ICSR processing, and regulatory compliance. This role is ideal for pharmacovigilance professionals with hands-on experience in literature review, case processing, and safety databases within a CRO or pharmaceutical environment.
The position contributes to global clinical trial and post-marketing safety operations, ensuring accurate, timely, and compliant safety reporting.
About Syneos Health
Syneos Health is a globally recognized biopharmaceutical solutions organization operating across 110+ countries with more than 29,000 professionals. Over the past five years, Syneos Health has supported 94% of FDA-approved novel drugs and 95% of EMA-authorized products, delivering excellence across clinical development, medical affairs, and pharmacovigilance.
Key Responsibilities
Perform end-to-end literature screening and safety review in accordance with regulatory and project-specific requirements
Enter, track, and manage Individual Case Safety Reports (ICSRs) in pharmacovigilance quality and safety databases
Triage ICSRs and assess cases for completeness, accuracy, and regulatory reportability
Perform case data entry, medical coding (MedDRA, WHO-DD), and narrative writing
Identify missing information, raise queries, and follow up to ensure timely resolution
Support expedited and periodic safety reporting in compliance with global regulations
Maintain safety tracking logs and quality documentation for assigned activities
Conduct drug coding and maintenance of drug dictionaries
Perform xEVMPD product record validation and submission, including MedDRA coding of indications
Support SPOR / IDMP-related pharmacovigilance activities
Identify and manage duplicate ICSRs
Perform quality review (QC) of safety cases
Ensure submission of safety documents to the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) as applicable
Maintain compliance with SOPs, Work Instructions, ICH-GCP, GVP, global safety regulations, and study-specific safety plans
Collaborate effectively with internal and external stakeholders
Participate in internal and regulatory audits when required
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline
Minimum 2+ years of experience in pharmacovigilance literature review
Hands-on experience in literature case processing and/or clinical trial case processing preferred
Experience with Drug Safety Triage databases for literature surveillance preferred
Working knowledge of safety databases and medical terminology
Strong understanding of clinical trial phases (II–IV), post-marketing safety, ICH-GCP, GVP, and global PV regulations
Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and safety workflow systems
Strong attention to detail, time management, and documentation skills
Ability to work independently and collaboratively in a team-based environment
Excellent written and verbal communication skills
Why Join Syneos Health
Exposure to global pharmacovigilance and drug safety projects
Structured learning, technical training, and career development opportunities
Inclusive, diverse, and employee-centric work culture
Opportunity to work on high-impact clinical trials and post-marketing programs
Competitive compensation and total rewards program
Equal Opportunity Statement
Syneos Health is an equal opportunity employer committed to building a diverse, inclusive, and accessible workplace. Candidates with transferable skills are encouraged to apply. Reasonable accommodations are provided in accordance with applicable laws.
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