Job Title: Safety & PV Specialist II (Literature Review)
Updated: October 29, 2025
Location: Madhapur, Telangana, India
Job ID: 25102422-OTHLOC-5449
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical, medical affairs, and commercial expertise, we deliver outcomes that align with modern market realities.
Our Clinical Development model puts the patient and customer at the center of everything we do. With more than 29,000 employees in 110 countries, we’ve 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 Us
Continuous career growth and progression opportunities.
Supportive management and technical/therapeutic training.
Recognition programs and comprehensive Total Rewards.
A Total Self culture that celebrates diversity, inclusion, and authenticity.
A global environment where everyone feels they belong.
Job Summary
The Safety & PV Specialist II (Literature Review) is responsible for conducting global and local literature searches to identify Individual Case Safety Reports (ICSRs), extracting relevant safety information, and processing cases per regulatory and company standards. This role ensures compliance with GVP, ICH, GCP, and global pharmacovigilance regulations for both clinical trials and post-marketing safety programs.
Key Responsibilities
Literature Review & Safety Data Identification
Conduct systematic and ad-hoc literature searches in biomedical databases (e.g., Embase, PubMed, Medline).
Extract and summarize key safety data from literature sources.
Design and validate search strategies for pharmacovigilance purposes.
Perform local literature searches in accordance with global and local regulatory requirements.
ICSR Processing & Management
Enter and track case data in PVG quality and tracking systems.
Triage ICSRs, assess completeness, accuracy, and reportability.
Code adverse events, medical history, and concomitant medications using MedDRA.
Write comprehensive narrative summaries for each safety case.
Manage and resolve data queries within timelines.
Coordinate with data management teams for reconciliation of safety and clinical databases.
Assist in the Safety Management Plan and ensure on-time submissions of expedited and periodic reports.
Compliance & Documentation
Maintain and update documentation in Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Participate in audits and inspections as needed.
Ensure adherence to SOPs, Work Instructions, GCP, GVP, and ICH guidelines.
Qualifications
Education
Bachelor’s or Postgraduate degree in Life Sciences, Pharmacy, Nursing, or related health discipline.
Equivalent combinations of education and experience will be considered.
Experience
Minimum 3+ years in Pharmacovigilance, with a focus on Global & Local Literature Case Review.
Strong experience identifying NICRs, safety signals, and adverse reactions from literature.
Solid understanding of GVP Module VI.
Familiarity with safety database systems and medical terminology.
Skills
Knowledge of clinical trial phases II–IV and post-marketing safety operations.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Visio) and collaborative tools (e.g., TeamShare).
Excellent written and verbal communication skills.
Strong organizational and multitasking abilities.
Attention to detail and commitment to accuracy.
Ability to work independently and within a team.
Willingness to travel occasionally (up to 5%).
Additional Information
Responsibilities listed are not exhaustive; additional duties may be assigned as needed.
The company complies with all applicable employment and equality laws, including the Americans with Disabilities Act (ADA).
Nothing in this description constitutes a binding employment contract.
How to Apply
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