Syneos Health Hiring Safety & Pharmacovigilance Specialist II

Syneos Health Hiring Safety & Pharmacovigilance Specialist II

Are you looking for an exciting career in drug safety and pharmacovigilance? Syneos Health is hiring Safety & Pharmacovigilance Specialist II for its Gurugram and Pune locations. If you have 3-5 years of experience in case processing, ICSR management, and regulatory compliance, this role is a great opportunity to advance your career.

Why Join Syneos Health?

Syneos Health is a global biopharmaceutical solutions company dedicated to accelerating the success of life-changing therapies. With over 29,000 employees across 110 countries, Syneos Health provides a collaborative work environment where professionals thrive.

Job Overview

Key Responsibilities:

• Process Individual Case Safety Reports (ICSRs) as per regulatory and company guidelines.
• Evaluate ICSR data for completeness, accuracy, and regulatory compliance.
• Enter data into safety databases and ensure quality assurance.
• Perform medical coding using MedDRA and maintain drug safety dictionaries.
• Generate timely, accurate, and consistent safety reports for clinical trials and post-marketing studies.
• Support safety data reconciliation between clinical and safety databases.
• Conduct literature screening and validation of xEVMPD product records.
• Participate in safety audits and inspections.
• Maintain compliance with global drug safety regulations, ICH GCP, GVP, and local regulatory requirements.

Required Qualifications & Experience

Education:

• Bachelor’s or Master’s degree in Pharmacy (B Pharm, M.Pharm), Biomedical Sciences (BDM, BMS) or Dentistry (BDS).

Experience:

• 3-5 years of experience in pharmacovigilance and drug safety.
• Hands-on experience with Safety Database Systems (ARGUS).
• Strong understanding of clinical trial processes (Phases II-IV) and post-marketing safety.
• Knowledge of medical terminology, MedDRA coding, and drug safety regulations.
• Excellent communication and organizational skills.

Work Location

• Gurugram & Pune, India

How to Apply?

If you meet the qualifications and are passionate about pharmacovigilance, don’t miss this opportunity! Click the link below to apply now:

👉 Apply Here

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