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 innovation, diversity, and career growth in the life sciences industry.
🔹 Why Join Syneos Health?
✔ Global Impact: Work on novel FDA/EMA-approved drugs and clinical trials.
✔ Career Growth: Continuous learning and professional development.
✔ Inclusive Culture: A Total Self culture fostering authenticity and belonging.
Job Description: Safety & PV Specialist I (Japanese Language Expert)
📍 Location: Gurugram, India
📌 Job ID: 25999949
Key Responsibilities:
- Process & Track ICSRs (Individual Case Safety Reports) per SOPs and regulatory requirements.
- Triage & Evaluate ICSR data for completeness, accuracy, and regulatory compliance.
- Enter & Code Data into safety databases (MedDRA coding, drug dictionary maintenance).
- Generate Expedited Reports in compliance with global pharmacovigilance regulations.
- Perform Literature Screening for safety data and adverse event monitoring.
- Manage SPOR/IDMP & xEVMPD submissions (product records, MedDRA coding).
- Quality Review & TMF (Trial Master File) compliance for clinical trials and post-marketing programs.
- Ensure adherence to GCP, ICH, GVP guidelines and company SOPs.
Eligibility & Qualifications
✅ Education:
- Master’s in Pharmacy (Preferred) OR
- Master’s in Science/Healthcare (or equivalent experience).
✅ Skills & Experience:
- Fluent in Japanese (Mandatory) for case processing and regulatory submissions.
- Strong knowledge of pharmacovigilance (PV) & drug safety regulations.
- Proficiency in Microsoft Office & safety databases.
- Attention to detail & ability to manage multiple tasks.
Benefits & Culture
💼 Career Development: Training, mentorship, and growth opportunities.
🌍 Global Collaboration: Work with diverse teams across 110 countries.
⚖ Work-Life Balance: Supportive and flexible work environment.
🏆 Recognition & Rewards: Competitive compensation and benefits.
