Senior Safety & Pharmacovigilance Specialist – Literature Case Processing & Review
Updated: February 3, 2026
Location: Gurgaon, Haryana, India (Office-Based)
Job ID: 25104484
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success across clinical development, medical affairs, and commercial operations. By transforming complex scientific and safety data into meaningful insights, Syneos Health supports the development and lifecycle management of innovative therapies worldwide.
With more than 29,000 employees across 110 countries, Syneos Health fosters a collaborative, patient-centric culture focused on operational excellence, regulatory compliance, and continuous professional growth.
Job Summary
The Senior Safety & Pharmacovigilance Specialist – Literature Case Processing & Review is responsible for end-to-end literature surveillance, safety case identification, and review activities in compliance with global and local pharmacovigilance regulations. This role serves as a subject matter expert in literature-based ICSR processing, regulatory reporting, and safety data quality, supporting both clinical trial and post-marketing programs.
The position requires strong expertise in global literature databases, safety regulations, and pharmacovigilance systems, along with the ability to independently manage workflows and mentor team members.
Key Responsibilities
Literature Surveillance and Safety Review
Conduct systematic and ad hoc literature searches across global biomedical databases such as Embase, PubMed, and MEDLINE to identify Individual Case Safety Reports (ICSRs) and safety-relevant information.
Design, validate, and optimize pharmacovigilance-focused literature search strategies in line with global and local regulatory requirements.
Extract, analyze, and summarize critical safety data from scientific publications and local literature sources.
Case Processing and Pharmacovigilance Operations
Process ICSRs in accordance with company SOPs and project-specific safety management plans.
Perform case triage, assess data completeness, accuracy, and regulatory reportability.
Enter and maintain ICSR data in validated safety databases, including medical coding for adverse events, medical history, concomitant medications, and diagnostic tests.
Prepare comprehensive case narratives and manage follow-up queries to resolution.
Support the preparation and timely submission of expedited and periodic safety reports in compliance with global regulatory timelines.
Regulatory Compliance and Quality Management
Ensure distribution of required expedited and periodic reports for clinical and post-marketing programs in coordination with Safety Submissions teams.
Maintain compliance with ICH-GCP, ICH-GVP, global safety regulations, company SOPs, and work instructions.
Prepare and maintain safety documentation within the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF) as applicable.
Participate in audits, inspections, and internal project review meetings as required.
Project Coordination and Subject Matter Expertise
Coordinate safety and literature workflows to ensure timely and high-quality project delivery.
Prepare Safety Management Plans and contribute to internal project governance activities.
Provide investigator training on ICSR reporting requirements.
Support trend analysis by establishing standards for data collection and safety signal monitoring.
Act as a subject matter expert, providing guidance, mentoring, and troubleshooting support to team members.
Identify risks or delivery issues and escalate appropriately to program leadership with proposed solutions.
Required Qualifications and Experience
Education
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Medicine, Dentistry, Biomedical Sciences, or related disciplines.
Accepted qualifications include B.Pharm, M.Pharm, PharmD, BDS, or BMS.
Experience
Minimum 5 years of hands-on experience in literature case processing within pharmacovigilance or drug safety functions.
Proven experience acting as a subject matter expert (SME) in literature surveillance and ICSR review.
Experience supporting clinical trial phases II–IV and/or post-marketing safety programs.
Technical and Professional Skills
Strong working knowledge of global biomedical literature databases and local literature review processes.
Proficiency in validated safety databases and medical terminology.
In-depth understanding of global and local pharmacovigilance regulations, including ICH-GCP and ICH-GVP.
Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and collaborative document management tools.
Excellent analytical, organizational, and prioritization skills with strong attention to detail.
Ability to work independently and collaboratively in cross-functional, global teams.
Strong written and verbal communication, presentation, and interpersonal skills.
Additional Requirements
Office-based role in Gurugram or Hyderabad.
Minimal travel may be required (up to 10%).
Why Join Syneos Health
Career development and progression supported by engaged leadership
Ongoing technical, regulatory, and therapeutic area training
Inclusive and diverse workplace culture focused on employee well-being
Opportunity to contribute to global drug safety and patient protection initiatives
Over the past five years, Syneos Health has supported 94% of novel FDA-approved drugs, 95% of EMA-authorized products, and more than 200 studies across 73,000 sites and 675,000+ clinical trial patients globally.
Additional Information
This job description is not exhaustive. Syneos Health reserves the right to assign additional responsibilities as business needs evolve. Equivalent combinations of education, skills, and experience may be considered. This posting does not constitute an employment contract. Syneos Health is an equal opportunity employer and complies with applicable employment and accessibility regulations.
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