Sr Safety & Pharmacovigilance Specialist – Literature Case Processing & Review
Company: Syneos Health
Job ID: 25104484
Employment Type: Full-Time
Work Model: Hybrid
Location: Gurugram or Hyderabad, India
Experience Required: Minimum 5+ years (Literature Case Processing with SME experience)
Qualification: B.Pharm / M.Pharm / PharmD / BDS / BMS
Company Overview
Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success across the drug development lifecycle. With operations in over 110 countries and a workforce of 29,000+ professionals, Syneos Health delivers integrated clinical, medical affairs, and commercial solutions that place patients at the center of innovation.
Role Overview
The Sr Safety & PV Specialist – Literature Case Processing & Review plays a critical role in global pharmacovigilance operations, with primary responsibility for systematic literature surveillance, ICSR identification, safety data review, and regulatory compliance. This position also functions as a Subject Matter Expert (SME), supporting team members, audits, and safety strategy execution.
Key Responsibilities
Literature Surveillance & Safety Review
Conduct systematic and ad-hoc literature searches using global biomedical databases (Embase, PubMed, Medline) for safety signal identification.
Develop, validate, and maintain search strategies for pharmacovigilance purposes.
Extract, assess, and summarize safety-relevant data from scientific literature.
Perform local literature reviews in compliance with regional and global regulatory requirements.
Ensure compliance with global and local literature monitoring regulations.
ICSR Processing & Case Management
Perform ICSR triage, assessment, and processing in accordance with SOPs and safety plans.
Evaluate cases for completeness, accuracy, and reportability.
Enter and code data in safety databases, including adverse events, medical history, concomitant medications, and laboratory tests.
Prepare high-quality narrative case summaries.
Identify missing information, raise queries, and ensure timely resolution.
Support expedited and periodic safety reporting in line with global regulations.
Coordinate reconciliation of safety data with clinical and data management teams.
Safety Operations & Compliance
Prepare and support Safety Management Plans (SMPs).
Coordinate project workflows to ensure timely and high-quality delivery.
Support safety submissions for clinical and post-marketing projects.
Ensure appropriate filing of documents in TMF and PSMF.
Participate in audits and inspections as required.
Maintain ongoing compliance with ICH-GCP, GVP, global safety regulations, SOPs, and WIs.
Subject Matter Expertise & Team Support
Act as an SME for literature case processing and safety operations.
Provide day-to-day technical guidance and troubleshooting support to team members.
Support trend analysis and safety signal activities.
Review program-level issues and escalate to Program Leads or Directors when required.
Train investigators on ICSR reporting requirements.
Required Qualifications & Skills
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.
Minimum 5+ years of hands-on experience in literature case processing, including SME responsibilities.
Strong knowledge of pharmacovigilance processes, clinical trials (Phases II–IV), and post-marketing safety.
Experience with global safety databases and medical terminology.
In-depth understanding of ICH-GCP, GVP, and global safety regulations.
Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and shared content platforms.
Strong analytical, organizational, and decision-making skills.
Excellent written and verbal communication skills.
Ability to manage multiple priorities with high attention to detail.
Willingness to travel minimally (up to 10%), if required.
Why Join Syneos Health
Work with a globally recognized organization involved in 94% of novel FDA-approved drugs and 95% of EMA-authorized products.
Be part of a diverse, inclusive, and collaborative culture focused on professional growth.
Access continuous learning, career development, and therapeutic area training.
Contribute to meaningful work that directly impacts patient safety worldwide.
Equal Opportunity Statement
Syneos Health is committed to providing equal employment opportunities and maintaining a workplace free from discrimination. Reasonable accommodations are available for qualified individuals with disabilities in accordance with applicable laws.
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