Senior Safety & Pharmacovigilance Specialist – Literature Case Processing & Review
Location: Gurugram, 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 global, fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial strategies. With a presence in over 110 countries and a workforce of more than 29,000 professionals, Syneos Health partners with leading pharmaceutical and biotech companies to accelerate drug development and improve patient outcomes worldwide.
The organization’s patient-centric Clinical Development model emphasizes innovation, regulatory excellence, and operational efficiency across clinical and post-marketing programs.
Job Summary
The Senior Safety & Pharmacovigilance Specialist (Literature Case Processing & Review) will be responsible for end-to-end pharmacovigilance activities with a primary focus on literature surveillance, Individual Case Safety Report (ICSR) processing, regulatory compliance, and safety data quality. This role requires strong subject matter expertise in global and local literature monitoring and safety reporting.
Key Responsibilities
Literature Surveillance & Safety Review
Perform systematic and ad-hoc literature searches in global biomedical databases including Embase, PubMed, and Medline to identify safety-relevant information and ICSRs.
Design, validate, and maintain pharmacovigilance-focused literature search strategies.
Extract, analyze, and summarize critical safety data from global and local literature sources.
Ensure compliance with global and country-specific regulatory requirements related to literature monitoring.
Pharmacovigilance & ICSR Processing
Process ICSRs in accordance with SOPs, project-specific safety plans, and regulatory guidelines.
Triage cases and assess data for completeness, accuracy, seriousness, and reportability.
Enter and manage safety data in pharmacovigilance databases, including coding of adverse events, medical history, concomitant medications, and laboratory tests.
Prepare high-quality narrative case summaries and manage follow-up activities until resolution.
Support the preparation and submission of expedited and periodic safety reports for clinical and post-marketing programs.
Compliance, Quality & Collaboration
Develop and maintain Safety Management Plans.
Participate in internal project review meetings and cross-functional discussions.
Coordinate with data management teams for reconciliation of safety and clinical data.
Ensure accurate filing of safety documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Participate in audits, inspections, and regulatory assessments.
Provide training to investigators and internal teams on ICSR reporting requirements.
Act as a Subject Matter Expert (SME), supporting team members with daily operational and technical guidance.
Contribute to safety trend analysis and continuous process improvement initiatives.
Required Qualifications
Education
Bachelor’s or Master’s degree in a relevant life sciences or healthcare discipline, including:
B.Pharm / M.Pharm
PharmD
BDS
BMS
Experience
Minimum 5 years of proven experience in literature case processing within pharmacovigilance, including SME-level responsibilities.
Strong exposure to global and local safety reporting requirements.
Technical & Regulatory Expertise
In-depth knowledge of ICH-GCP, GVP, global pharmacovigilance regulations, and drug development processes.
Experience across clinical trial phases II–IV and post-marketing safety.
Hands-on experience with safety databases and medical terminology standards.
Professional Skills
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and document management systems.
Strong analytical, organizational, and decision-making abilities.
Excellent written and verbal communication skills.
Ability to work independently and collaboratively in a cross-functional environment.
High attention to detail with the ability to manage multiple priorities and meet strict timelines.
Work Location & Travel
Location: Gurugram, India (Office-Based Role)
Travel Requirement: Minimal (up to 10%)
Why Join Syneos Health
Opportunity to work on global safety programs supporting FDA- and EMA-approved products
Career growth through structured learning, leadership support, and technical training
Inclusive, diverse, and collaborative workplace culture
Direct contribution 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 clinical trial and post-marketing patients worldwide.
Apply Now
Qualified pharmacovigilance professionals with strong expertise in literature case processing are encouraged to apply through ThePharmaDaily.com and advance their careers in global drug safety.
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