Sr. Safety Specialist (Literature Review)
Location: Hyderabad, India
Updated: October 29, 2025
Job ID: 25102421
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into impactful outcomes that address modern healthcare challenges.
Our Clinical Development model puts the customer and patient at the center of everything we do. With a team of over 29,000 employees across 110 countries, we have supported:
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 Syneos Health
At Syneos Health, we focus on developing our people through:
Continuous career development, technical training, and growth opportunities
Supportive and engaged leadership
A Total Self culture — encouraging authenticity, diversity, and inclusion
Recognition and total rewards programs
We are committed to creating a workplace where everyone feels they belong and can thrive both personally and professionally.
Position Overview
As a Senior Safety Specialist (Literature Review), you will play a key role in pharmacovigilance operations, conducting systematic and ad-hoc literature searches to identify Individual Case Safety Reports (ICSRs) and other safety-relevant information. This position requires expertise in biomedical databases, literature search strategies, and regulatory requirements for global and local literature surveillance.
Key Responsibilities
Conduct systematic and ad-hoc literature searches in biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety information.
Extract and summarize key safety data from identified literature sources.
Develop and validate search strategies in compliance with pharmacovigilance standards.
Perform local and global literature reviews in alignment with regulatory requirements.
Coordinate workflow to ensure timely project delivery and quality standards.
Prepare and maintain Safety Management Plans and participate in internal project reviews.
Enter, process, and reconcile ICSR data in safety databases per SOPs and project plans.
Assess ICSR completeness, code medical terms, and compile narrative summaries.
Support regulatory submissions by ensuring accurate distribution of expedited and periodic reports.
Train investigators on ICSR reporting procedures.
Participate in audits/inspections and maintain compliance with GCP, GVP, ICH, and other global regulations.
Ensure all documents are archived 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 field (Pharmacy, Nursing, Life Sciences) or equivalent experience.
Experience: Minimum 5 years of experience in Pharmacovigilance with strong exposure to:
Literature case review (Global + Local)
Identification of NICRs, Signals, and Adverse Reactions from literature
Quality checks, citation reviews, and workflow management
Training/mentoring of junior team members and QC oversight
Skills & Competencies
Strong understanding of medical terminology and the literature review process.
Excellent knowledge of major databases: Embase, PubMed, Medline, etc.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Visio).
Familiarity with Safety Database systems and data entry processes.
Comprehensive understanding of clinical trial phases (II–IV), post-marketing safety, ICH-GCP, and GVP.
Exceptional organizational, analytical, and decision-making skills.
Ability to manage multiple tasks independently and under deadlines.
Strong written and verbal communication and leadership skills.
Additional Information
Travel: Up to 10% (minimal).
This job description is not exhaustive and may be revised as needed.
Equivalent combinations of education and experience will be considered.
Syneos Health is an Equal Opportunity Employer, committed to compliance with the EU Equality Directive and the Americans with Disabilities Act (ADA), including reasonable accommodations when required.
Apply Now
Interested candidates can apply via the Syneos Health Careers Portal or join our Talent Network to stay updated on upcoming roles.
At Syneos Health, we value transferable skills and encourage you to apply even if your experience does not align perfectly with every qualification.
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