Job Title: Sr Safety Specialist (Literature Review)
Updated On: October 29, 2025
Location: Hyderabad, India
Job ID: 25102421
Organization: Syneos Health®
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by integrating clinical, medical affairs, and commercial expertise. With over 29,000 employees across 110 countries, the company brings both the customer and the patient to the center of every process to drive innovation and efficiency in clinical development.
Key Facts:
Partnered with 94% of FDA-approved novel drugs and 95% of EMA-authorized products in the past five years.
Involved in 200+ studies, 73,000 sites, and 675,000+ trial patients globally.
Committed to a “Total Self” culture, fostering authenticity, inclusivity, and career growth.
The Sr Safety Specialist (Literature Review) is responsible for conducting global and local literature searches to identify individual case safety reports (ICSRs) and other safety-relevant data. This role ensures compliance with regulatory requirements and contributes to the overall safety monitoring of investigational and marketed products.
Conduct systematic and ad-hoc searches in global biomedical databases (e.g., Embase, PubMed, Medline).
Identify and extract safety-relevant information from literature sources.
Develop and validate literature search strategies for pharmacovigilance (PV) purposes.
Perform global and local literature reviews to detect ICSRs and signal reports.
Enter ICSR data into safety databases according to SOPs and project-specific safety plans.
Perform case triage, data entry, medical coding, and narrative writing.
Ensure completeness, accuracy, and regulatory reportability of ICSRs.
Coordinate data reconciliation between clinical and safety databases.
Prepare Safety Management Plans and participate in internal project review meetings.
Ensure submission of expedited and periodic safety reports to the Safety Submissions team.
Maintain Trial Master File (TMF) documentation and Pharmacovigilance System Master File compliance.
Ensure all work adheres to SOPs, WIs, GVP, GCP, ICH guidelines, and project-specific requirements.
Participate in audits and inspections as required.
Conduct quality checks, citation reviews, and lead internal team discussions.
Provide training and mentoring to team members and investigators on ICSR reporting.
Support workflow management, task allocation, and quality control functions.
Education:
Bachelor’s or postgraduate degree in a health-related discipline (Pharmacy, Nursing, Life Sciences, or equivalent).
Experience:
Minimum 5 years of pharmacovigilance experience with strong exposure to literature case review (global and local).
Experience identifying NICR (Signal & Adverse Reaction) reports from literature.
Proven record in quality review, training, and workflow coordination.
Technical Skills:
Expertise in biomedical databases (Embase, PubMed, Medline).
Proficiency in Microsoft Office (Word, Excel, PowerPoint), Visio, and TeamShare.
Strong understanding of safety databases, medical terminology, and regulatory reporting.
Soft Skills:
Excellent written and verbal communication.
Strong organizational and time management abilities.
Detail-oriented, with a high level of accuracy and decision-making ability.
Ability to work independently and within a global team environment.
Other Requirements:
Minimal travel (up to 10%) may be required.
Job responsibilities are not exhaustive and may evolve per project needs.
Equivalent experience, education, or skills may be considered.
Syneos Health complies with the Americans with Disabilities Act (ADA) and offers reasonable accommodations when appropriate.
Interested candidates are encouraged to apply directly or join the Syneos Health Talent Network for future opportunities.
Learn more: www.syneoshealth.com
Recent Related Roles:
Safety & PV Specialist II (MIS)
Safety Specialist II – Clinical Trial Experience (Hybrid)
Safety & PV Specialist II (Literature Review)
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