Safety & PV Specialist I – Literature Review
Location: India – Pune
Job Type: Full-Time
Job ID: 25104540
Updated: December 23, 2025
About Syneos Health
Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform clinical, medical affairs, and commercial insights into actionable outcomes for modern healthcare challenges.
With over 29,000 employees across 110 countries, Syneos Health provides an environment that fosters collaboration, innovation, and professional growth, enabling employees to contribute meaningfully to drug development and patient care worldwide.
Position Overview
The Safety & PV Specialist I (Literature Review) is responsible for performing high-quality pharmacovigilance activities with a focus on literature review, case processing, and safety reporting. The role ensures timely, accurate, and compliant management of Individual Case Safety Reports (ICSRs) and contributes to maintaining global safety standards.
Key Responsibilities
Case Processing & Data Management:
Receive, triage, and enter ICSRs into PVG or designated safety databases.
Evaluate ICSRs for completeness, accuracy, and regulatory reportability.
Perform coding of adverse events, medical history, concomitant medications, and tests using MedDRA.
Identify and manage duplicate ICSRs.
Maintain safety tracking for assigned activities.
Perform SAE reconciliation and quality reviews.
Literature Review & Regulatory Compliance:
Conduct literature screening and review for safety signals, case processing, and coding updates.
Validate and submit xEVMPD product records, ensuring accurate indication coding.
Apply regulatory intelligence and comply with SOPs, GCP, ICH, and GVP guidelines.
Participate in audits and inspections as required.
Collaboration & Documentation:
Compile narrative summaries and follow up on queries to ensure completeness of information.
Ensure all relevant documentation is submitted to the Trial Master File (TMF) or Pharmacovigilance System Master File.
Liaise with internal teams and external stakeholders to resolve safety issues.
Maintain detailed documentation for inspection readiness.
Quality & Process Improvement:
Perform manual and automated recoding of un-recoded terms.
Apply quality control processes for literature case handling and data entry.
Contribute to the development and maintenance of safety and PV processes.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or equivalent.
Minimum 2+ years of literature review experience; experience in ICSR and clinical trial case processing preferred.
Knowledge of pharmacovigilance databases, medical terminology, and safety reporting regulations.
Understanding of clinical trial phases II–IV, post-marketing safety requirements, and regulatory frameworks (GCP, ICH, GVP).
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and teamwork/collaboration tools.
Strong communication, organizational, and time management skills with high attention to detail.
Ability to work independently and as part of a team.
Why Join Syneos Health
Contribute to global drug safety and pharmacovigilance programs impacting patient health worldwide.
Work in a collaborative and inclusive environment with opportunities for mentorship and career growth.
Gain exposure to cutting-edge clinical trials and post-marketing safety practices.
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Frank Scottile Blvd |Missouri :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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