Here is the rewritten job description in UHG Format Pro as requested:
Job Title: Safety & PV Specialist II
Company: Syneos Health
Location: Tokyo, Japan
Job ID: 25002905
About Syneos Health:
Syneos Health® is a leading integrated biopharmaceutical solutions organization focused on accelerating customer success. With a global presence of over 29,000 employees across 110 countries, Syneos Health combines clinical, medical affairs, and commercial capabilities to deliver better outcomes. Our work centers on simplifying processes, driving innovation, and ultimately improving lives.
Why Join Us:
Career growth opportunities through structured development and progression
A culture of authenticity with our “Total Self” approach
Diverse and inclusive environment that fosters a sense of belonging
Recognition programs and comprehensive rewards
Access to world-class training and mentorship
Job Summary:
The Safety & Pharmacovigilance Specialist II supports pharmacovigilance activities including processing and reporting of Individual Case Safety Reports (ICSRs), data quality review, and regulatory compliance, across both clinical trials and post-marketing programs.
Key Responsibilities:
Enter and track ICSRs in PVG systems
Support creation of project-specific plans like Safety Management Plan
Assist in the set-up, delivery, and closure of PV projects
Process and triage ICSRs as per SOPs and safety plans
Enter safety data, code events and medications, and compile narrative summaries
Resolve data queries and ensure information completeness
Generate timely and accurate expedited safety reports
Coordinate with Data Management on safety data reconciliation
Maintain safety tracking systems and perform literature review
Code product terms using MedDRA and validate xEVMPD product records
Identify and manage duplicate ICSRs
Engage in SPOR / IDMP-related activities
Conduct quality reviews of ICSRs and peer work
Mentor, coach, and train new hires; act as a subject matter expert in SPVG
Apply regulatory intelligence to safety reporting
Ensure appropriate distribution of safety reports to the Safety Submissions team
Participate in audits/inspections as required
Ensure document compliance with TMF and PSMF standards
Adhere to SOPs, WIs, global regulations, ICH GCP, GVP, and safety protocols
Qualifications:
Bachelor’s degree in life sciences, pharmacy, or nursing (or equivalent experience)
Strong understanding of medical terminology and safety database systems
Solid knowledge of ICH GCP, GVP, and safety regulations (Phases II–IV and post-marketing)
Proficient in Microsoft Office Suite, Visio, and shared content tools
Excellent written and verbal communication skills
Ability to work independently and collaboratively in a fast-paced environment
Exceptional organizational and multitasking skills with high attention to detail
Willingness to travel occasionally (up to 5%)
Additional Information:
Responsibilities and tasks may be revised at the company’s discretion.
Equivalent education and experience may be considered.
Committed to ADA compliance and reasonable accommodations.
About Syneos Health’s Impact:
Syneos Health has supported 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the last 5 years, with involvement in over 200 studies across 73,000 sites and more than 675,000 patients.
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China | Quarry Bay |Hubei :
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Lyon | Paris |Attica :
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Netanya | Kfar Saba | Be'Er Sheva | Tel Aviv | Yavne |Italy :
Italy |Lombardy :
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Remote, USA | Melbourne | Lenexa | Victoria | Switzerland | Remote - Europe | Remote - Middle East | Remote - Africa | Remote - South America (Latin Americal) | Leinster | McFarland | Remote |Bucharest :
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King Abdullah Economic City | Rabigh | Khulais | Jeddah | Riyadh | Najran |Nišava District :
Niš |Singapore :
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