Safety Specialist II – ICSR Case Processing (Hyderabad | Hybrid)
Job ID: 25103877
Updated: December 5, 2025
Location: Hyderabad, India (Hybrid)
Employer: Syneos Health
Position Overview
Syneos Health is seeking a Safety Specialist II with strong expertise in ICSR Case Processing to support its global Pharmacovigilance operations. This hybrid role—based in Hyderabad—contributes to high-quality safety reporting, regulatory compliance, and efficient case management across international programs.
As part of a fully integrated biopharmaceutical solutions organization, the Safety Specialist II plays a key role in ensuring patient safety, accuracy of safety data, and adherence to global PV standards.
Key Responsibilities
ICSR Case Handling and Processing
Enter and manage safety data in PV quality and tracking systems.
Process ICSRs according to Standard Operating Procedures (SOPs) and project-specific safety plans.
Perform ICSR triage, completeness checks, data validation, and regulatory reportability assessment.
Code adverse events, medical history, laboratory results, and concomitant medications using MedDRA.
Prepare complete and medically consistent narrative summaries.
Identify missing information, raise queries, and ensure timely resolution.
Regulatory Reporting and Compliance
Support the preparation and submission of expedited safety reports in alignment with global regulatory timelines.
Maintain safety activity trackers and documentation repositories.
Conduct literature screening and contribute to drug dictionary and MedDRA maintenance.
Validate and submit xEVMPD product records, including accurate indication coding.
Quality Oversight and Data Management
Perform manual recoding of product and substance terms when required.
Identify and manage duplicate ICSRs.
Contribute to SPOR/IDMP-related activities.
Conduct quality review of processed ICSRs.
Ensure appropriate documentation is uploaded to the Trial Master File (TMF) and PV System Master File.
Cross-Functional Collaboration
Adhere to SOPs, Work Instructions, ICH guidelines, GCP, GVP, and all relevant global regulations.
Maintain strong professional relationships with internal teams and external partners.
Participate in audits when required.
Apply Syneos Health’s regulatory intelligence to safety reporting practices.
Qualifications and Experience Required
Education
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or an equivalent field.
Experience
Minimum 2–4 years of experience in Pharmacovigilance with hands-on ICSR case processing (required for Safety Specialist II).
Understanding of clinical trial phases II–IV and post-marketing safety requirements.
Experience working with global PV regulations including ICH GCP and GVP.
Technical Skills
Proficiency in safety database systems and medical terminology.
Strong command of Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, Visio, and shared workspaces.
Experience with MedDRA coding, literature screening, and safety tracking tools.
Core Competencies
Excellent communication and interpersonal skills.
Strong time management and organizational abilities.
High attention to detail with the capability to meet stringent deadlines.
Ability to work independently and within cross-functional teams.
About Syneos Health
Syneos Health is a global leader in biopharmaceutical solutions, operating in more than 110 countries with a workforce of over 29,000 professionals. Over the past five years, the company has partnered on 94 percent of all FDA-approved novel drugs and 95 percent of EMA-authorized products.
To learn more, visit syneoshealth.com
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