Job Title: Senior Manager, Patient Safety (Snr Mgr PS)
Location: Tokyo, Japan
Category: Clinical
Job ID: 254746
Lead and manage the Patient Safety Solutions (PSS) team, including performance management, resource allocation, and operational oversight of PSS activities. Ensure compliance with regulatory requirements and maintain high-quality service delivery for clients. Manage the complete adverse event process for clinical trial and post-marketing products, including expedited safety reports.
Leadership & Team Management
Line manage PSS staff, including performance reviews, HR issues, and staff development.
Assign resources to projects in collaboration with Senior PSS Management.
Oversee team training and ensure records are up to date.
Mentor PSS managers and junior staff.
Participate in recruitment, interviews, and onboarding of new team members.
Support departmental training curriculum development and improvement.
Project & Client Oversight
Lead 1–2 key projects and provide oversight to cross-department PSS operations.
Ensure workflow management and timely, compliant safety reporting.
Escalate operational issues to Senior Management as needed.
Build and maintain strong client relationships and act as a strategic liaison.
Participate in proposal development, budgeting, and strategic client engagement.
Adverse Event & Safety Operations
Oversee receipt, processing, and reporting of all adverse events (AEs) and serious adverse events (SAEs) from clinical trials or spontaneous sources.
Ensure accurate data entry into safety databases and proper coding of AEs using MedDRA.
Validate listedness/expectedness and perform follow-up queries as needed.
Ensure cases receive appropriate medical review.
Oversee expedited safety report (ESR) processing and endpoint reporting to clients, regulatory authorities, ethics committees, investigators, and Fortrea personnel.
Supervise quality review of AE reports and aggregate reports.
Oversee signal detection, trend analysis, and pattern recognition activities.
Ensure timely preparation of Safety Management Plans (SMPs), Reconciliation Plans, and pharmacovigilance reports.
Provide oversight of EudraVigilance activities and local safety database configuration/migration.
Compliance & Quality
Ensure team compliance with international reporting regulations, SOPs, and safety processing guidelines.
Support audits, client inspections, and regulatory submissions.
Maintain comprehensive understanding of PSS SOPs, Work Instructions (WIs), guidance documents, and regulatory directives.
Oversee maintenance of adverse event reporting documentation in assigned countries.
Contribute to operational metrics, SOP development, and departmental improvement initiatives.
Strategic Initiatives
Lead or assist with ad-hoc strategic initiatives.
Propose and execute innovative solutions to enhance project and departmental performance.
Manage overall project budgets, timelines, and resources.
Support Clinical Data Management (CDM) in SAE reconciliation.
Contribute to Clinical Trial Protocols, Case Report Forms, and adverse event reporting form reviews.
Education & Experience
Degree preferred in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field.
Relevant experience in pharmaceutical, biotechnology, or CRO industry.
Safety experience includes AE/SAE processing, narratives, queries, regulatory submissions, and database management.
Team leadership experience with line or project management responsibility.
Knowledge of Medical Device Reporting and aggregate reporting desirable.
Experience Requirements (Preferred)
Non-degree + 10 yrs safety experience.
Associate degree + 8–9 yrs safety experience.
BS/BA + 6–7 yrs relevant experience.
MS/MA + 5–6 yrs relevant experience (or 4–5 yrs safety experience).
PhD / PharmD + 3–4 yrs relevant experience (or 2–3 yrs safety experience) + 1–2 yrs team leadership.
Fluency in Japanese and English (speaking, reading, writing).
3–4 yrs line management and/or project management experience preferred.
Skills & Competencies
Strong leadership and mentoring abilities.
Excellent verbal, written, and presentation skills.
Ability to multitask, prioritize, and anticipate issues.
Knowledge of global regulatory requirements, GCP, ICH guidelines, and local Japanese GCP/GVP regulations.
Strong understanding of financial management, proposal development, and budgeting.
Vendor management experience.
Knowledge of medical and drug terminology.
High accuracy and attention to detail.
Proficiency in MS Office and Windows; knowledge of safety databases preferred.
Office-based environment.
Travel required: 10–15% (including overnight stays as necessary).
Compliance with Health and Safety regulations and company policies.
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