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Safety & Pv Specialist Ii

0-2 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.