Job Title: Safety & PV Specialist II (Literature Review)
Updated: October 29, 2025
Location: Gurgaon, Haryana, India
Job ID: 25102422
Company: Syneos Health®
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by combining clinical, medical affairs, and commercial expertise. Our Clinical Development Model keeps patients and customers at the center of everything we do, continuously simplifying and optimizing our processes to make Syneos Health both easier to work with—and easier to work for.
With 29,000 employees across 110 countries, we’ve collaborated with:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000 sites and 675,000+ trial patients
Work Here Matters Everywhere.
Why Join Us
Continuous career development and progression opportunities.
Supportive line management and dedicated technical/therapeutic area training.
Recognition programs and Total Rewards system.
A Total Self culture where authenticity and diversity are celebrated.
A truly inclusive environment where everyone feels they belong.
Job Summary
The Safety & PV Specialist II (Literature Review) performs end-to-end pharmacovigilance (PV) activities related to literature search, ICSR processing, and safety data review. The role ensures compliance with global regulatory guidelines (GVP, ICH, GCP) across both clinical and post-marketing settings.
Key Responsibilities
Literature Review & Case Identification
Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline).
Identify ICSRs and safety-relevant information from literature sources.
Develop and validate search strategies aligned with PV regulatory requirements.
Perform local literature searches and reviews as per global and local regulations.
ICSR Processing
Enter and track safety data in PVG quality systems.
Triage ICSRs for completeness, accuracy, and reportability.
Code events, medical history, concomitant medications, and tests using MedDRA.
Write comprehensive narrative summaries for safety cases.
Manage data queries and ensure resolution.
Coordinate with data management for safety–clinical database reconciliation.
Support the Safety Management Plan and timely regulatory submissions.
Compliance & Documentation
Ensure distribution of expedited and periodic reports per SOPs.
Support audits and inspections as required.
Maintain Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) documentation.
Stay updated with SOPs, WIs, GCP, GVP, and ICH guidelines.
Qualifications & Experience
Education
Bachelor’s or Postgraduate degree in Life Sciences, Pharmacy, Nursing, or related health discipline.
Equivalent combination of education and experience considered.
Experience
Minimum 3+ years of experience in Pharmacovigilance and Literature Case Review (Global + Local).
Hands-on experience in NICR identification, signal detection, and adverse reaction reporting.
Strong knowledge of GVP Module VI.
Proficiency with safety databases and medical terminology.
Skills
Excellent understanding of clinical trial phases (II–IV) and post-marketing safety.
Familiarity with ICH-GCP, GVP, and global regulatory requirements.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Visio) and shared platforms (e.g., TeamShare).
Strong communication, organizational, and time management skills.
Detail-oriented with ability to manage multiple projects.
Able to work independently or collaboratively.
Minimal travel required (up to 5%).
Additional Information
Tasks and responsibilities listed are not exhaustive; additional duties may be assigned as needed.
The company ensures full compliance with applicable equal employment and disability laws, including the Americans with Disabilities Act (ADA).
No part of this description constitutes an employment contract.
How to Apply
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