Job Title: Sr. Safety Specialist (Literature Review)
Updated: October 29, 2025
Location: Madhapur, Telangana, India
Job ID: 25102421-OTHLOC-5449
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by combining clinical development, medical affairs, and commercial expertise.
Our Clinical Development model places both the customer and patient at the core of every process. We continuously innovate to simplify operations, strengthen collaboration, and make Syneos Health easier to work with — and for.
With 29,000+ employees across 110 countries, we have supported:
94% of all novel FDA-approved drugs in the last 5 years
95% of EMA-authorized products
200+ studies conducted across 73,000 sites and 675,000+ trial patients
WORK HERE MATTERS EVERYWHERE
Why Join Us
Career development and clear progression pathways
Strong leadership support and technical/therapeutic area training
Peer recognition and total rewards programs
Inclusive Total Self Culture — be authentic, be valued, and belong
Diverse teams collaborating globally to drive innovation and impact lives
Position Overview
The Senior Safety Specialist (Literature Review) plays a key role in pharmacovigilance activities through comprehensive literature screening, safety data evaluation, and ICSR identification. The role involves working with global biomedical databases, ensuring regulatory compliance, managing project workflows, and providing mentorship to junior PV professionals.
Key Responsibilities
1. Literature Review & Safety Data Management
Conduct systematic and ad-hoc literature searches in biomedical databases (Embase, PubMed, Medline) to identify ICSRs and safety-relevant data.
Develop and validate literature search strategies for pharmacovigilance purposes.
Perform both global and local literature reviews in compliance with GVP Module VI and local regulatory requirements.
Extract, evaluate, and summarize key safety information from literature sources.
Maintain accurate documentation of all literature activities and findings.
2. Case Processing & Safety Operations
Process ICSRs in compliance with SOPs and project-specific safety management plans.
Perform case triage, data evaluation, medical coding (MedDRA), and narrative writing.
Conduct data entry into the safety database and ensure completeness and accuracy.
Support expedited and periodic report generation according to regulatory timelines.
Reconcile safety data with clinical data management systems.
3. Project Coordination & Compliance
Prepare and maintain Safety Management Plans.
Coordinate workflows to ensure timely delivery of project outputs.
Participate in internal project review meetings and contribute to PV documentation.
Ensure all safety-related documents are filed in TMF and PSMF as per SOPs.
Participate in audits/inspections and support CAPA implementations if required.
4. Training & Mentoring
Train investigators on ICSR reporting and literature search best practices.
Mentor team members and provide oversight on QC and work allocation.
Lead internal discussions on literature findings and quality improvements.
Qualifications & Experience
Education:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, or a related health discipline.
Experience:
Minimum 5 years of experience in Pharmacovigilance, including global and local literature case review.
Strong experience identifying NICRs (Signals & Aggregate Reports) from literature.
Proven exposure to quality checks, citation reviews, and internal meeting leadership.
Prior experience mentoring or supervising PV teams preferred.
Technical Competencies:
Expertise in literature databases (Embase, PubMed, Medline).
Familiarity with safety databases (e.g., Argus, ArisG).
Deep understanding of medical terminology, clinical trial phases II–IV, and post-marketing PV requirements.
In-depth knowledge of ICH GCP, GVP, global PV regulations, and reporting standards.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, and TeamShare.
Soft Skills:
Excellent written and verbal communication.
Strong organizational and multitasking abilities.
High attention to detail with the ability to meet strict deadlines.
Independent problem-solving with team collaboration mindset.
Travel Requirement:
Minimal (up to 10%)
Additional Information
The listed responsibilities are not exhaustive; additional tasks may be assigned based on business needs.
Equivalent combinations of education and experience may be considered.
Syneos Health complies with the Americans with Disabilities Act and provides reasonable accommodations when required.
We are an Equal Opportunity Employer, fostering diversity, inclusion, and respect across all roles and levels.
Application Details
Interested candidates can apply via the Syneos Health Careers Portal or join the Talent Network for future opportunities.
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