Job Title: Safety Specialist II – Clinical Trial Experience (Hybrid)
Updated: October 31, 2025
Location: Yerawada, Maharashtra, India
Job ID: 25102440-OTHLOC-5448-2DH
Company Overview – Syneos Health®
Syneos Health® is a global biopharmaceutical solutions organization dedicated to accelerating customer success through integrated clinical, medical affairs, and commercial expertise.
Operates in 110 countries with over 29,000 employees.
Partnered with 94% of all FDA-approved drugs and 95% of EMA-authorized products in the past five years.
Delivered 200+ studies across 73,000 sites and 675,000+ clinical trial patients.
Philosophy: “Work Here Matters Everywhere.”
Position Summary
The Safety Specialist II plays a critical role in managing clinical trial safety data. The position requires strong experience in clinical trial pharmacovigilance and involves hybrid (on-site + remote) work setup.
This role ensures compliance with global safety reporting requirements and supports the continuous improvement of safety processes across projects.
Key Responsibilities
Process and evaluate Adverse Events (AEs) and Serious Adverse Events (SAEs) in compliance with applicable regulations and guidelines.
Conduct data entry, narrative writing, coding (MedDRA, WHO Drug), and case quality checks in safety databases.
Support timely case submissions (ICSRs) to regulatory authorities and sponsors.
Perform safety data reconciliation with clinical data management teams.
Collaborate with medical reviewers and clinical teams to ensure case accuracy.
Participate in audit and inspection activities to ensure compliance readiness.
Contribute to preparation of aggregate safety reports (e.g., DSURs, PSURs).
Identify and communicate potential quality or compliance risks.
Qualifications & Skills
Education:
Degree in Pharmacy, Life Sciences, Biotechnology, or related field.
Experience:
Minimum 2 years of experience in Pharmacovigilance or Clinical Trial Safety (mandatory).
Technical Skills:
Proficiency in clinical safety databases (e.g., Argus, ArisG).
Knowledge of ICSR processing, MedDRA coding, literature review, and regulatory timelines.
Familiarity with global safety regulations (ICH E2A/E2B, GVP modules).
Soft Skills:
Strong attention to detail and data accuracy.
Excellent written and verbal communication.
Good team collaboration and time management skills.
Why Join Syneos Health
Continuous career development and progression opportunities.
Supportive leadership and technical/therapeutic area training.
Recognition through Total Rewards and Peer Appreciation programs.
Inclusive and diverse Total Self culture that values authenticity.
Hybrid work model promoting flexibility and work-life balance.
Additional Information
Responsibilities may be adjusted based on project needs.
Equivalent education and experience will be considered.
Committed to compliance with the EU Equality Directive and ADA (Americans with Disabilities Act), ensuring fair and inclusive employment practices.
How to Apply
Visit: www.syneoshealth.com
Or join the Syneos Health Talent Network to stay updated on similar opportunities.
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