Job Summary:
Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Safety & PV Specialist I (Japanese Language Expert) in Gurgaon, India. This full-time, on-site role focuses on pharmacovigilance operations, including ICSR processing, safety database management, MedDRA coding, and regulatory report submissions. Ideal for candidates passionate about clinical safety, regulatory compliance, and drug development processes.
Key Responsibilities:
Enter and track ICSRs in PVG systems.
Process ICSRs per SOPs and safety plans.
Triaging and evaluation of ICSR data for completeness and accuracy.
Perform MedDRA coding for medical terms, drug coding, and narrative writing.
Conduct literature screening for drug safety.
Validate and submit xEVMPD product records.
Identify and manage duplicate ICSRs.
Support SPOR/IDMP-related activities.
Ensure all documentation aligns with TMF and PSMF standards.
Participate in internal audits and quality reviews.
Collaborate with internal/external teams for smooth safety operations.
Required Skills & Qualifications:
Proven experience in pharmacovigilance or clinical safety operations.
Knowledge of MedDRA coding, ICH guidelines, GVP, GCP, and global regulatory frameworks.
Familiarity with xEVMPD, SPOR/IDMP processes.
Strong attention to detail with case processing capabilities.
Excellent command of the Japanese language.
Good interpersonal and team collaboration skills.
Perks & Benefits:
Career development & progression opportunities.
Supportive work culture under the Total Self initiative.
Recognition programs & total rewards structure.
Access to technical and therapeutic area training.
Opportunity to work in a global pharmaceutical environment.
Company Description:
Syneos Health is a top-tier biopharmaceutical solutions company supporting 94% of FDA novel drug approvals and over 200 global clinical studies. The organization empowers teams through training, career advancement, and a culture that values diversity and collaboration.
Work Mode:
On-site – Gurgaon, India
Call-to-Action:
Ready to advance your career in pharmacovigilance? Apply now to become a part of Syneos Health’s global team and contribute to impactful clinical solutions.
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