Safety Specialist II – ICSR Case Processing (Pune | Hybrid)
Job ID: 25103877
Updated: December 5, 2025
Location: Pune, India (Hybrid)
Employer: Syneos Health
About the Role
Syneos Health is seeking a Safety Specialist II specializing in ICSR Case Processing to support global Pharmacovigilance operations. This role requires strong knowledge of safety systems, regulatory requirements, ICSR management, and high-quality case processing aligned with global PV standards.
This position is based in Pune with a hybrid work model and collaborates closely with teams in Gurgaon and Hyderabad.
Key Responsibilities
ICSR Case Processing
Enter required data into Pharmacovigilance quality and tracking systems.
Assist in end-to-end processing of ICSRs following SOPs, WI, and project-specific safety plans.
Perform ICSR triage, completeness checks, accuracy verification, and regulatory reportability assessment.
Code adverse events, medical history, tests, and concomitant medications using MedDRA.
Prepare complete, medically coherent narrative summaries.
Identify missing information, raise queries, and ensure closure.
Regulatory Reporting & Safety Compliance
Support timely preparation and submission of expedited regulatory reports.
Maintain safety activity trackers and documentation.
Conduct literature screening and MedDRA coding activities.
Validate and submit xEVMPD product records, including indication term coding.
Data Integrity & Quality Oversight
Perform manual recoding of product and substance terms when required.
Identify and manage duplicate ICSRs.
Support SPOR/IDMP-related activities.
Conduct quality reviews of processed ICSRs.
Ensure documentation is uploaded to TMF and the PV System Master File as per requirements.
Cross-Functional Collaboration
Maintain compliance with SOPs, WIs, global regulations (ICH, GVP, GCP), and PV processes.
Maintain strong professional relationships with internal and external stakeholders.
Participate in audits as needed.
Apply global regulatory intelligence in all safety reporting tasks.
Qualifications and Experience Required
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent qualification.
Experience
2–4 years of hands-on experience in Pharmacovigilance and ICSR case processing (preferred for Safety Specialist II).
Practical understanding of clinical trial phases (II–IV) and post-marketing safety requirements.
Prior experience with global PV regulations (ICH GCP, GVP) is essential.
Technical Skills
Proficiency with safety databases and medical terminology.
Strong command of Microsoft Office tools (Word, Excel, PowerPoint), Outlook, and collaborative workspaces.
Familiarity with MedDRA coding, drug dictionaries, and safety data management.
Soft Skills
Excellent written and verbal communication skills.
Strong organizational abilities with capacity to manage multiple tasks.
High attention to detail and ability to meet strict deadlines.
Ability to work both independently and in a team environment.
About Syneos Health
Syneos Health is a global biopharmaceutical solutions organization operating across 110 countries with more than 29,000 employees. The company has supported 94% of all Novel FDA-approved drugs and 95% of EMA-authorized products in the past five years. Syneos Health fosters a culture focused on growth, development, inclusion, and scientific excellence.
Learn more: syneoshealth.com
Additional Information
Responsibilities listed in this description are not exhaustive. Syneos Health may assign additional tasks as needed. Equivalent experience, skills, or education may be considered. This description complies with applicable global employment regulations. Reasonable accommodation is available for qualified applicants with disabilities.
Apply for This Job
Interested candidates can apply directly through The Pharma Daily job portal or join the Syneos Health Talent Network to stay informed about future opportunities.
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