✅ Safety Specialist II — Structured Job Description
Position Details
Role: Safety Specialist II (Clinical Trial Experience – MUST HAVE)
Location: Pune, India (Hybrid)
Company: Syneos Health
Job ID: 25102440
Updated On: 31 October 2025
✅ About Syneos Health
Syneos Health is a global biopharmaceutical solutions organization that integrates clinical development, medical affairs, and commercial capabilities to support faster, high-quality drug development.
Operations across 110+ countries
Workforce of 29,000+ professionals
Involved with 94% of Novel FDA-approved drugs in the last 5 years
Contributed to 95% of EMA-authorized products
✅ Why Work at Syneos Health
Strong culture focused on authenticity (Total Self Culture)
Career growth and structured development programs
Supportive and engaged leadership
Technical and therapeutic area training available
Peer recognition and comprehensive rewards program
Diverse and inclusive global environment
✅ Role Summary
Safety Specialist II supports clinical trial safety operations by processing, evaluating, and reporting safety data in compliance with global regulatory requirements. The role ensures high-quality safety case handling and contributes to patient safety within clinical research programs.
(This posting refers to the standard Safety & PV Specialist II responsibilities.)
✅ Key Responsibilities (Typical Safety Specialist II Duties)
1. Case Processing & Medical Review
Perform triage, data entry, and processing of adverse events (AEs) and serious adverse events (SAEs)
Perform medical assessment: seriousness, causality, expectedness
Prepare high-quality narrative summaries
Conduct follow-ups with study sites to obtain missing information
2. Regulatory Compliance
Ensure all safety reports meet global regulatory timelines (7-day/15-day reporting)
Maintain compliance with:
ICH-GCP
FDA/EMA safety reporting
Local health authority regulations
3. Data Quality & Documentation
Ensure accuracy and completeness of safety data in the safety database
Support reconciliation between clinical (eCRF) and safety systems
Perform quality checks on processed cases
Contribute to audit/inspection readiness
4. Cross-Functional Collaboration
Collaborate with:
Clinical operations
Data management
Medical monitors
Regulatory safety teams
Participate in safety-related project meetings
5. Additional/Supportive Tasks
Assist with preparation of periodic safety reports, line listings, study safety summaries
Maintain safety documentation and logs
Support system access/setup for study personnel
Contribute to process improvements and workflow optimization
✅ Additional Information
Tasks listed are not exhaustive; the company may assign additional responsibilities
Equivalent education/experience may be considered
Reasonable accommodation available under ADA for applicants needing support
Not an employment contract; responsibilities may change based on project needs
✅ Application Prompt
Syneos encourages applicants from diverse backgrounds who may not meet 100% of the listed experience. Candidates can join the Talent Network to stay updated on future roles.
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Arkansas | Remote Australia |New South Wales :
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