Job Summary:
Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Safety & PV Specialist I (Japanese Language Expert) for its Gurgaon location. This full-time, on-site role is ideal for professionals skilled in pharmacovigilance and fluent in Japanese, contributing to global drug safety and clinical trial processes. Join a team that shapes the future of drug development and regulatory excellence.
Key Responsibilities:
Handle and track Individual Case Safety Reports (ICSRs) in PVG systems.
Conduct case triage and assess completeness, accuracy, and reportability.
Perform MedDRA coding, drug coding, and narrative preparation.
Conduct literature screening and review for safety signals.
Validate and submit xEVMPD product records with proper MedDRA coding.
Manage duplicate ICSRs and SPOR/IDMP-related activities.
Perform quality reviews of safety cases.
Ensure documentation for TMF and PSMF in compliance with SOPs and regulatory standards.
Participate in internal and external audits as required.
Collaborate with global teams for smooth pharmacovigilance operations.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or equivalent.
Prior experience in pharmacovigilance, clinical safety, or drug safety operations.
Knowledge of MedDRA coding, ICH-GCP, GVP guidelines, and PV databases.
Familiarity with xEVMPD and SPOR/IDMP processes.
Proficiency in Japanese language (mandatory).
Excellent attention to detail and problem-solving skills.
Strong communication and teamwork abilities.
Perks & Benefits:
Global exposure with leading biopharmaceutical clients.
Career development and training programs.
Supportive, inclusive work culture under "Total Self" initiative.
Recognition and total rewards programs.
Opportunity to work on innovative drug development projects.
Company Description:
Syneos Health is a top-tier integrated biopharmaceutical solutions provider, supporting 94% of all FDA-approved novel drugs. With over 29,000 professionals across 110 countries, the company drives clinical development and commercial success globally.
Work Mode:
On-site – Gurgaon, India
Call-to-Action:
Interested in advancing your pharmacovigilance career? Apply now to join Syneos Health’s dynamic team and contribute to global drug safety excellence.
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