Job Title: Safety Specialist II – Clinical Trial Experience (Hybrid)
Updated: October 31, 2025
Location: Madhapur, Telangana, India
Job ID: 25102440-OTHLOC-5449-2DH
Company Overview – Syneos Health®
Syneos Health® is a global biopharmaceutical solutions organization committed to accelerating customer success through integrated clinical, medical affairs, and commercial insights.
Operating across 110 countries with 29,000+ employees.
Partnered on 94% of FDA-approved drugs and 95% of EMA-authorized products in the last 5 years.
Conducted 200+ studies across 73,000 sites and 675,000+ trial patients.
Motto: “Work Here Matters Everywhere.”
Position Summary
The Safety Specialist II is responsible for evaluating, processing, and reporting clinical trial safety data in compliance with global regulatory standards and company policies. The role requires prior clinical trial experience and offers a hybrid working model.
Key Responsibilities
Perform case processing activities for clinical trial safety data, ensuring accuracy and regulatory compliance.
Review adverse event (AE) and serious adverse event (SAE) information for clinical trial subjects.
Prepare and submit individual case safety reports (ICSRs) to relevant health authorities.
Collaborate with clinical operations, medical writing, and pharmacovigilance teams for safety deliverables.
Support ongoing safety data reconciliation and quality control activities.
Contribute to safety-related documentation, including DSURs, line listings, and summary tabulations.
Participate in audits and inspections to ensure compliance with internal and regulatory requirements.
Requirements
Essential:
Experience: Minimum 2 years in pharmacovigilance or clinical safety related to clinical trials.
Education: Degree in pharmacy, life sciences, or a related field.
Skills:
Excellent understanding of clinical safety processes.
Strong attention to detail, data accuracy, and documentation skills.
Effective communication and teamwork abilities.
Proficiency with safety databases and MS Office tools.
Work Culture & Benefits
Career growth through training, mentorship, and performance development.
Recognition through peer awards and total rewards programs.
Inclusive culture promoting authenticity, diversity, and belonging.
Hybrid model ensuring flexibility and work-life balance.
Additional Information
Tasks and responsibilities may vary based on project needs.
Equivalent experience or education will be considered.
The company adheres to all applicable employment equality and disability compliance laws (including ADA).
How to Apply
Visit: www.syneoshealth.com
or join the Syneos Health Talent Network to stay informed about upcoming opportunities.
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