Job Title: Safety Specialist II – Clinical Trial Experience (Must Have)
Location: Gurgaon, Haryana, India
Job Type: Hybrid
Updated On: October 31, 2025
Job ID: 25102440
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that partners with customers to accelerate clinical and commercial success. The company combines clinical, medical affairs, and commercial expertise to deliver innovative outcomes that meet modern healthcare challenges.
With 29,000 employees in over 110 countries, Syneos Health brings together a unique blend of data-driven insight, scientific expertise, and global collaboration.
Why Join Syneos Health
🚀 Career Development: Comprehensive learning and growth opportunities.
🤝 Supportive Leadership: Engaged managers and strong peer recognition culture.
🌍 Inclusive Environment: “Total Self” culture where authenticity and diversity are valued.
🧠 Continuous Learning: Technical, therapeutic, and regulatory training programs.
💡 Purpose-Driven Work: Each project contributes to improving patients’ lives globally.
Key Achievements
Over the past 5 years, Syneos Health has collaborated on:
94% of all Novel FDA-Approved Drugs
95% of EMA-Authorized Products
200+ studies, across 73,000 sites, and 675,000+ trial patients
Role Overview
As a Safety Specialist II (Clinical Trial Experience), you will be responsible for ensuring the safety and regulatory compliance of investigational products in clinical studies. You will collaborate across global teams to ensure accurate case processing, timely reporting, and data integrity.
Core Responsibilities
Perform clinical trial safety data review and case processing activities.
Ensure compliance with ICH-GCP, company SOPs, and regulatory requirements.
Manage and process adverse event (AE) and serious adverse event (SAE) reports.
Support narrative writing, causality assessment, and medical review coordination.
Participate in preparation of safety summaries, aggregate reports, and regulatory submissions.
Collaborate with cross-functional teams to improve workflow efficiency and data quality.
Maintain accurate safety documentation within global safety databases.
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, or related discipline.
Prior experience in Clinical Trials or Pharmacovigilance is mandatory.
Strong understanding of clinical safety regulations, MedDRA, and global reporting timelines.
Excellent analytical, written, and communication skills.
Proficiency in safety databases and Microsoft Office tools.
Additional Information
Responsibilities listed are not exhaustive and may evolve with project needs.
Equivalent combinations of education and experience will be considered.
Syneos Health adheres to global employment and equality regulations, including the EU Equality Directive and the Americans with Disabilities Act (ADA).
Reasonable accommodations are available for applicants or employees as required.
How to Apply
🔗 Apply Now on Syneos Health Careers
💬 Not ready to apply? Join the Syneos Talent Network to stay updated on future openings.
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