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Japanese Language Expert - Safety & Pv Specialist

2+ years
Not Disclosed
10 Jan. 7, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Position: Safety & Pharmacovigilance Specialist I
Location: Remote/Field

About Syneos Health:
Syneos Health® is a leading biopharmaceutical solutions organization designed to accelerate customer success. We bring clinical, medical, and commercial insights to life, helping our clients navigate modern market challenges. Our approach centers on putting customers and patients at the heart of everything we do, while simplifying processes to ensure efficiency and ease.

As part of Syneos Health, you’ll collaborate with dynamic problem-solvers, working in an agile environment to innovate and drive the delivery of therapies that improve lives.

Why Syneos Health:
We are committed to career development, offering training, progression, and recognition to our people. Our inclusive culture fosters diversity of thought, backgrounds, and experiences, making Syneos Health a place where everyone can feel like they belong.

Job Responsibilities:

  • Coordinate workflows and ensure timely delivery of projects.
  • Distribute and monitor team workloads, escalating issues regarding deliverables, finances, and quality.
  • Support the management of safety and pharmacovigilance risks and issues.
  • Assist in preparing project plans, including Safety Management Plans, and participate in internal project review meetings.
  • May enter and track ICSRs in SPVG systems, process data according to SOPs, and ensure regulatory reportability.
  • Code events, medical history, medications, and tests; compile complete narrative summaries.
  • Assess data completeness and accuracy, following up to resolve queries.
  • Assist in generating timely, consistent reports, and coordinate data reconciliation with clinical teams.
  • Participate in quality control of literature screening, drug coding, and MedDRA coding.
  • Handle the validation and submission of xEVMPD product records, including coding indication terms with MedDRA.
  • Manage duplicate ICSRs and participate in SPOR/IDMP activities.
  • Review the quality of ICSRs and peer-reviewed work.
  • Provide mentoring, coaching, and training to team members.
  • Ensure distribution of expedited and periodic reports for both clinical and post-marketing projects.
  • Maintain Trial Master File (TMF) compliance for clinical trials and Pharmacovigilance System Master File for post-marketing programs.
  • Apply safety reporting intelligence and regulatory compliance (GVP, ICH guidelines) to all activities.

Qualifications:

  • Bachelor's degree in life sciences, nursing, pharmacy, or equivalent education/experience.
  • In-depth knowledge of clinical trial processes, ICH GCP, GVP, and safety regulations.
  • Proficient in safety database systems and medical terminology.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, and Outlook.
  • Strong communication, organizational, and interpersonal skills.
  • Excellent ability to prioritize tasks and work across multiple projects.
  • Ability to work independently and in a collaborative team environment.
  • Minimal travel may be required (up to 10%).

Why Work With Us:
Syneos Health works with top-tier biopharmaceutical companies and has supported 94% of novel FDA-approved drugs. We provide an environment where you can challenge the status quo and contribute to meaningful, global change in clinical trials and drug development.

Apply Now:
If this role resonates with your experience and career goals, apply now. You are also encouraged to join our Talent Network for future opportunities.