Sr. Safety Specialist (Literature Review)
Location: Gurugram, India
Updated: October 29, 2025
Job ID: 25102421
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that partners with clients to accelerate the delivery of life-changing therapies. We combine clinical, medical affairs, and commercial expertise to translate insights into real-world impact.
Our Clinical Development model puts the customer and patient at the center of all we do. With over 29,000 employees in 110 countries, we bring innovation and agility to a dynamic healthcare environment — driven by our passion to change lives.
Work Here Matters Everywhere.
Why Join Syneos Health
At Syneos Health, we invest in our people through:
Career development and progression programs
Technical and therapeutic area training
Peer recognition and total rewards systems
A global Total Self culture, where authenticity and inclusion are valued
We believe that diversity of thought, background, and perspective builds a workplace where everyone feels they belong.
Role Overview
The Senior Safety Specialist (Literature Review) is responsible for conducting and managing global and local literature reviews to identify Individual Case Safety Reports (ICSRs) and safety-relevant information for pharmacovigilance activities. This role demands expertise in biomedical databases, regulatory requirements, and safety data management.
Key Responsibilities
Conduct systematic and ad-hoc literature searches in databases such as Embase, PubMed, and Medline for ICSR identification and safety insights.
Extract, summarize, and interpret key safety data from literature sources.
Develop and validate literature search strategies in compliance with global PV requirements.
Perform global and local literature reviews according to regulatory standards.
Coordinate project workflows and ensure timely deliverables.
Prepare and maintain Safety Management Plans; assist in internal project review meetings.
Enter and track ICSR data in PVG quality systems per SOPs and study-specific plans.
Triages and evaluates ICSR completeness, accuracy, and regulatory reportability.
Code medical history, events, and concomitant medications; prepare narrative summaries.
Support regulatory submission of expedited and periodic safety reports.
Participate in audits and inspections, ensuring compliance with all PV, GCP, and ICH guidelines.
Provide investigator training on ICSR reporting.
Maintain documentation in the Trial Master File (TMF) or Pharmacovigilance System Master File (PSMF) as applicable.
Qualifications & Experience
Education: Bachelor’s or Postgraduate degree in a health-related discipline (Pharmacy, Nursing, or Life Sciences) or equivalent experience.
Experience: Minimum 5 years in Pharmacovigilance with specialization in:
Global and local literature case review
Identification of NICR, Signal, and Adverse Reaction reports from literature
Quality checks, citation reviews, and internal review leadership
Technical Expertise:
Proficient in Embase, PubMed, and other major biomedical databases
Strong command of medical terminology and literature review processes
Hands-on experience with safety database systems and Microsoft Office Suite
Working knowledge of ICH GCP, GVP, and global PV regulations
Core Skills
Excellent analytical, organizational, and decision-making abilities
Strong written and verbal communication skills
Ability to mentor, train, and coordinate teams
High attention to detail and ability to meet deadlines under pressure
Capable of working independently and within a collaborative environment
Additional Details
Travel: Up to 10% (minimal).
This job description is not exhaustive; additional tasks may be assigned as needed.
Syneos Health values equivalent combinations of education and experience.
Committed to Equal Opportunity Employment, the EU Equality Directive, and the Americans with Disabilities Act (ADA), ensuring reasonable accommodations for all qualified individuals.
Learn More
Over the past five years, Syneos Health has contributed to:
94% of all Novel FDA-Approved Drugs
95% of EMA-Authorized Products
200+ Studies across 73,000 Sites and 675,000+ Trial Patients
For more information, visit: www.syneoshealth.com
How to Apply
Interested applicants can apply through the Syneos Health Careers Portal or join our Talent Network to stay informed about future opportunities.
At Syneos Health, we welcome applicants from diverse backgrounds — even if your experience doesn’t align perfectly with every qualification, we encourage you to apply.
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