Syneos Health is seeking a Safety & Pharmacovigilance (PV) Specialist I with Japanese language proficiency to join their team in Pune. This role is critical in ensuring drug safety and compliance with global pharmacovigilance regulations.
Key Responsibilities:
- Enter and track Individual Case Safety Reports (ICSRs) in PVG quality systems.
- Assist in processing ICSRs following SOPs and safety plans.
- Triage ICSRs, evaluate data for accuracy, completeness, and regulatory compliance.
- Perform MedDRA coding for adverse events, medical history, and concomitant medications.
- Generate narrative summaries and ensure timely submission of expedited reports.
- Conduct literature screening for safety information and maintain drug dictionaries.
- Validate and submit xEVMPD product records with appropriate MedDRA coding.
- Manage duplicate ICSRs and support SPOR/IDMP activities.
- Ensure compliance with ICH-GCP, GVP, and global regulatory requirements.
- Participate in audits and maintain Trial Master File (TMF) documentation.
Qualifications & Skills:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- Experience in pharmacovigilance, drug safety, or clinical research.
- Proficiency in Japanese (reading/writing) for case processing.
- Knowledge of safety databases (Argus, ARISg, Veeva) and medical terminology.
- Familiarity with ICH-GCP, GVP, and global safety regulations.
- Strong organizational skills with the ability to prioritize multiple tasks.
- Excellent communication and teamwork abilities.
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, accelerating customer success through clinical, medical affairs, and commercial expertise. With 29,000+ employees across 110 countries, Syneos Health is committed to transforming patient lives by simplifying drug development and improving market access.
Why Join Syneos Health?
✅ Career Growth: Continuous learning and professional development.
✅ Inclusive Culture: A “Total Self” environment where diversity is celebrated.
✅ Impactful Work: Contribute to 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products.
✅ Global Collaboration: Work with passionate professionals in clinical trials and post-marketing safety.
How to Apply
