Sr Safety & Pharmacovigilance Specialist – Literature Case Processing & Review
Location: Hyderabad, India (Office-based)
Job Type: Full-Time
Experience Required: Minimum 5 Years
Last Updated: January 8, 2026
Job ID: 25104484
About the Company
Syneos Health® is a leading global biopharmaceutical solutions organization, delivering integrated clinical development, medical affairs, and commercial services. With operations across 110+ countries and a workforce of over 29,000 professionals, Syneos Health partners with top pharmaceutical and biotech companies to accelerate the delivery of innovative therapies that improve patient lives worldwide.
Our patient-centric Clinical Development model focuses on operational excellence, innovation, and regulatory compliance, enabling faster and more efficient drug development across clinical and post-marketing phases.
Job Overview
The Senior Safety & Pharmacovigilance Specialist (Literature Case Processing & Review) will play a critical role in global pharmacovigilance activities, with a strong focus on literature monitoring, Individual Case Safety Report (ICSR) processing, regulatory compliance, and safety data quality. This role requires subject matter expertise in literature case processing and end-to-end pharmacovigilance operations.
Key Responsibilities
Literature Surveillance & Safety Review
Conduct systematic and ad-hoc literature searches using global biomedical databases such as Embase, PubMed, and Medline to identify ICSRs and safety-relevant data.
Develop, validate, and optimize literature search strategies for pharmacovigilance purposes.
Extract, analyze, and summarize critical safety information from published literature and local sources.
Ensure compliance with global and local regulatory requirements related to literature monitoring.
Pharmacovigilance Operations & ICSR Processing
Perform end-to-end processing of ICSRs in accordance with SOPs, safety management plans, and regulatory guidelines.
Triage and assess ICSRs for completeness, accuracy, seriousness, and reportability.
Enter and manage safety data in pharmacovigilance databases, including medical coding of adverse events, medical history, concomitant medications, and laboratory data.
Prepare high-quality narrative case summaries and manage follow-ups until query resolution.
Support the timely submission of expedited and periodic safety reports in line with global regulations.
Compliance, Quality & Collaboration
Prepare and maintain Safety Management Plans and contribute to internal project review meetings.
Coordinate with data management, clinical, and regulatory teams for safety data reconciliation.
Ensure accurate and timely filing of documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Participate in audits, inspections, and regulatory reviews as required.
Provide training and guidance to investigators and internal teams on ICSR reporting requirements.
Act as a Subject Matter Expert (SME), supporting team members with troubleshooting and process improvements.
Required Qualifications & Skills
Education
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or Healthcare, including:
B.Pharm / M.Pharm
PharmD
BDS
BMS
Experience
Minimum 5 years of hands-on experience in literature case processing and pharmacovigilance, including SME responsibilities.
Strong exposure to global and local literature surveillance and safety reporting requirements.
Technical & Regulatory Knowledge
In-depth understanding of ICH-GCP, GVP, global safety regulations, and pharmacovigilance practices.
Experience across clinical trial phases II–IV and post-marketing safety.
Working knowledge of safety databases and medical terminology.
Professional Skills
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and document management systems.
Strong analytical, organizational, and problem-solving skills.
Excellent written and verbal communication skills.
Ability to manage multiple priorities independently while working effectively within cross-functional teams.
High attention to detail with a commitment to data quality and regulatory compliance.
Work Location & Travel
Location: Hyderabad, India (Office-based role)
Travel Requirement: Minimal (up to 10%)
Why Join Syneos Health
Work on global safety programs supporting FDA- and EMA-approved therapies
Career development through continuous learning and leadership support
Inclusive and diverse workplace culture
Opportunity to contribute to patient safety and regulatory excellence on a global scale
Over the past five years, Syneos Health has supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, impacting hundreds of thousands of patients worldwide.
Apply Now
If you are an experienced pharmacovigilance professional with strong expertise in literature case processing and safety review, apply today through ThePharmaDaily.com and advance your career in global drug safety.
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