Syneos Healthยฎ 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.
๐น Why Join Syneos Health?
โ Global Impact: Work on novel FDA/EMA-approved drugs and clinical trials.
โ Career Growth: Continuous learning and professional development.
โ Inclusive Culture: A Total Self culture fostering authenticity and belonging.
Job Description: Safety & PV Specialist I (Japanese Language Expert)
๐ Location: Gurugram, India
๐ Job ID: 25999949
Key Responsibilities:
- Process & Track ICSRsย (Individual Case Safety Reports) per SOPs and regulatory requirements.
- Triage & Evaluate ICSR dataย for completeness, accuracy, and regulatory compliance.
- Enter & Code Dataย into safety databases (MedDRA coding, drug dictionary maintenance).
- Generate Expedited Reportsย in compliance with global pharmacovigilance regulations.
- Perform Literature Screeningย for safety data and adverse event monitoring.
- Manage SPOR/IDMP & xEVMPD submissionsย (product records, MedDRA coding).
- Quality Review & TMF (Trial Master File) complianceย for clinical trials and post-marketing programs.
- Ensure adherence to GCP, ICH, GVP guidelinesย and company SOPs.
Eligibility & Qualifications
โ Education:
- Masterโs in Pharmacy (Preferred)ย OR
- Masterโs in Science/Healthcareย (or equivalent experience).
โ Skills & Experience:
- Fluent in Japanese (Mandatory)ย 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
๐ผ Career Development: Training, mentorship, and growth opportunities.
๐ Global Collaboration: Work with diverse teams across 110 countries.
โ Work-Life Balance: Supportive and flexible work environment.
๐ Recognition & Rewards: Competitive compensation and benefits.