Job Title: Sr. Safety Specialist (Literature Review)
Updated: October 29, 2025
Location: Gurgaon, Haryana, India
Job ID: 25102421
Company: Syneos Health®
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization that partners with clients to accelerate clinical and commercial success. We bridge the gap between clinical development, medical affairs, and commercialization, delivering outcomes that meet modern healthcare demands.
Our Clinical Development model keeps the customer and patient at the center of everything we do. We continuously innovate to simplify, streamline, and enhance collaboration — making Syneos Health both a great partner and a great place to work.
With a presence in 110 countries and a workforce of 29,000+ employees, we have contributed to:
94% of all novel FDA-approved drugs in the past 5 years
95% of EMA-authorized products
200+ studies across 73,000 sites and 675,000+ trial patients
At Syneos Health, WORK HERE MATTERS EVERYWHERE.
Why Join Us
Strong focus on career development, progression, and skill enhancement
Access to technical and therapeutic area training and peer recognition programs
Supportive leadership fostering engagement and growth
A global Total Self Culture that celebrates authenticity, diversity, and inclusion
Collaborative teams that challenge the status quo and innovate to improve patient outcomes
Position Summary
The Sr. Safety Specialist (Literature Review) is responsible for conducting systematic and ad-hoc literature searches to identify potential adverse event cases, safety signals, and relevant safety information from biomedical databases. This role plays a critical part in maintaining regulatory compliance, supporting case processing activities, and contributing to the overall pharmacovigilance (PV) and safety surveillance framework.
Key Responsibilities
Literature Search & Review
Conduct systematic and ad-hoc literature searches in biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.
Develop and validate search strategies aligned with pharmacovigilance objectives.
Perform global and local literature searches, ensuring compliance with regulatory requirements (EMA, FDA, ICH, GVP).
Extract, summarize, and analyze key safety data and ensure accurate documentation.
Safety Case Management
Triaging and evaluating ICSRs for completeness, accuracy, and reportability.
Data entry and coding of adverse events, medical history, and concomitant medications.
Preparation of narrative summaries and follow-up on data queries.
Support preparation of Safety Management Plans and participate in internal project review meetings.
Coordinate with data management teams to reconcile safety data between clinical and PV databases.
Regulatory & Quality Oversight
Ensure timely and accurate reporting of expedited and periodic safety reports.
Maintain compliance with company SOPs, WIs, GCP, ICH, and GVP guidelines.
Ensure all relevant documentation is filed in Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF).
Participate in audits/inspections and provide training to Investigators on ICSR reporting.
Team Leadership & Collaboration
Mentor junior team members and oversee work allocation and quality control activities.
Participate in project planning and coordination to ensure timely delivery of PV deliverables.
Lead internal meetings, contribute to continuous improvement, and uphold quality standards.
Qualifications
Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or related health profession.
Experience: Minimum 5 years of experience in Pharmacovigilance, with focus on literature case review (global + local) and NICR (signal/aggregate report) identification.
Technical Skills:
Proficiency in literature databases (Embase, PubMed, Medline)
Knowledge of safety databases (Argus, ArisG, etc.)
Strong understanding of medical terminology and clinical trial processes (Phases II–IV)
Familiarity with ICH GCP, GVP, and global PV regulations
Soft Skills:
Excellent communication and organizational skills
Strong analytical and decision-making abilities
Attention to detail with proven time management
Capable of mentoring, training, and managing workflows
Tools: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, and TeamShare.
Travel: Minimal (up to 10%).
Additional Information
Tasks and duties listed are not exhaustive; the company may assign additional responsibilities.
Equivalent combinations of education and experience will be considered.
Syneos Health is an Equal Opportunity Employer, committed to diversity, inclusion, and providing reasonable accommodations in compliance with global laws.
How to Apply
Interested candidates can apply directly through the Syneos Health careers portal or join the Talent Network to receive updates on future opportunities.
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