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?
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Company & Job Details Table
| Company Name | Current Vacancies | Required Education | Experience Required | Location |
|---|---|---|---|---|
| Syneos Health | Safety & Pharmacovigilance Specialist II | B.Pharm, M.Pharm, BDM, BMS, BDS | 3-5 years | Gurugram, Pune |
To apply for this job please visit www.syneoshealth.com.