✅ Safety Specialist II — Structured Job Description
Position Details
Role: Safety Specialist II (Clinical Trial Experience – MUST HAVE)
Location: Hyderabad, India (Hybrid)
Company: Syneos Health
Job ID: 25102440
Updated On: 31 October 2025
✅ About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions organization supporting end-to-end drug development. With 29,000+ employees across 110+ countries, the company focuses on accelerating clinical development and delivering high-quality, patient-centered outcomes.
Work Here Matters Everywhere — a culture built on innovation, collaboration, and a commitment to improving lives.
✅ Why Work at Syneos Health
Strong culture of inclusion (Total Self Culture)
Career development & advancement programs
Technical and therapeutic area training
Peer recognition and rewards program
Supportive line management & global collaborative environment
Diverse workforce that encourages authenticity
✅ Required Qualifications / Must-Have
(Job posting references full details under the “Safety & PV Specialist II” description — below is the structured expected profile for Safety Specialist II roles at Syneos Health)
Education
Bachelor’s degree in Life Sciences / Pharmacy / Nursing / Health Sciences
Equivalent education + experience may be considered
Experience
Mandatory: Clinical Trial Safety / Pharmacovigilance experience
Experience with:
Case processing for AEs/SAEs
Clinical trial safety reporting
Narrative writing
Safety database systems (e.g., Argus, ArisG, Veeva Safety)
Knowledge of:
ICH-GCP
Global safety regulations
Clinical research processes
Skills
Strong written and verbal communication
High attention to detail
Strong analytical and medical interpretation skills
Ability to collaborate cross-functionally
Good computer and documentation skills
Ability to work in fast-paced, deadline-driven environments
✅ General Role Description
Safety Specialist II is responsible for handling and evaluating clinical trial safety data. The role ensures accurate processing, assessment, and reporting of safety information in compliance with regulatory requirements.
The role contributes to patient safety, regulatory compliance, and overall quality of clinical development programs.
✅ Core Responsibilities
(Aligned with typical Safety Specialist II expectations at Syneos Health)
1. Case Processing
Perform triage, data entry, and processing of AEs/SAEs
Assess seriousness, expectedness, causality, and medical relevance
Generate high-quality safety narratives
Query resolution with clinical sites
2. Regulatory Compliance
Ensure case submissions meet global timelines (e.g., 7-day/15-day reporting)
Maintain compliance with:
ICH-GCP
FDA/EMA regulations
Local Health Authority requirements
3. Safety Data Quality
Perform quality checks on processed cases
Ensure data integrity and completeness in the safety database
Reconcile safety data with clinical trial data (eCRF vs. Safety DB)
4. Collaboration & Project Support
Work closely with:
Clinical teams
Medical monitors
Data management
Regulatory safety groups
Participate in team meetings and safety discussions
5. Documentation & Reporting
Maintain safety-related documents
Prepare line listings, summary reports, and periodic safety updates
Support SAE reconciliation & audit readiness
6. Additional Duties
Perform study-specific training activities
Support audits/inspections with necessary documentation
Assist in process improvement and workflow optimization
✅ Additional Information
Job duties described are not exhaustive
Company may assign additional tasks based on business needs
Reasonable accommodations provided for applicants with disabilities
Equivalent experience may be considered even if profile doesn’t perfectly match
✅ Summary
Safety Specialist II ensures high-quality processing, assessment, and regulatory-compliant reporting of safety data in clinical trials. The role contributes significantly to patient safety, regulatory compliance, and the overall success of clinical development programs.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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