Safety Specialist II – ICSR Case Processing (Gurugram | Hyderabad)
Job ID: 25103877
Updated: December 5, 2025
Location: Gurugram, India
Role Overview
Syneos Health is seeking a Safety Specialist II with expertise in ICSR Case Processing to support global Pharmacovigilance operations. This role is based in Gurugram, with collaboration across India and international teams. The position contributes to patient safety, regulatory compliance, and end-to-end case processing within a rapidly evolving biopharmaceutical environment.
Syneos Health is a fully integrated biopharmaceutical solutions organization, operating across 110 countries with more than 29,000 professionals. The company combines clinical, medical affairs, and commercial insights to accelerate development and improve outcomes.
Key Responsibilities
ICSR Processing and Data Management
Enter and manage case data in PVG quality and tracking systems.
Process ICSRs according to SOPs, Work Instructions, and program-specific safety plans.
Perform ICSR triage, completeness checks, regulatory reportability assessment, and database entry.
Code adverse events, medical history, lab data, and concomitant medications using MedDRA.
Prepare accurate narrative summaries with high medical and scientific clarity.
Identify missing information and manage queries until resolution.
Regulatory Reporting and Compliance
Support timely preparation and submission of expedited safety reports according to global regulations.
Maintain safety trackers and documentation for assigned programs.
Conduct literature screening, drug coding, and maintenance of safety dictionaries.
Validate and submit xEVMPD product records with correct MedDRA indication coding.
Quality and Operational Excellence
Identify and resolve duplicate ICSRs.
Perform manual recoding of product and substance terms when required.
Participate in SPOR/IDMP-related activities.
Conduct quality review of processed ICSRs.
Ensure documentation is uploaded to the Trial Master File (TMF) or PV System Master File as required.
Cross-Functional Collaboration
Maintain full compliance with SOPs, GCP, ICH guidelines, GVP, and global PV regulations.
Collaborate with internal teams and external partners to ensure operational efficiency.
Participate in audits and apply regulatory intelligence to case processing activities.
Required Qualifications and Skills
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent qualification.
Experience
2 to 4 years of hands-on experience in Pharmacovigilance with direct involvement in ICSR case processing.
Experience in global regulatory requirements, ICH GCP, GVP, and clinical trial safety processes.
Technical Competencies
Proficiency in safety database systems and medical terminology.
Strong knowledge of MedDRA coding and literature screening.
Skilled in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, Visio, and shared content management platforms.
Core Skills
Strong written and verbal communication abilities.
Detail-oriented approach with high accuracy.
Ability to manage multiple tasks, meet strict timelines, and work both independently and as part of a team.
Strong organizational and interpersonal skills.
About Syneos Health
Syneos Health has collaborated on 94 percent of all FDA-approved novel drugs and 95 percent of EMA-authorized products over the past five years. The organization is committed to professional growth, continuous learning, and a culture that values authenticity, diversity, and inclusion.
More information is available at the official Syneos Health website.
Additional Information
Responsibilities listed may evolve based on organizational needs. Equivalent experience or education may be considered based on internal standards. The company adheres to all global employment regulations and provides reasonable accommodations when needed.
How to Apply
Candidates can apply directly through The Pharma Daily job portal.
Applicants who wish to stay informed about future opportunities may join the Syneos Health Talent Network.
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