Freelance Pharmacovigilance Auditor GVP／GPSP監査員・安全性情報監査コンサルタント（業務委託）

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

JAPAN (NATIONWIDE) | FREELANCE CONTRACT | ON-SITE / REMOTE | NATIVE-LEVEL JAPANESE

THE OPPORTUNITY

ProPharma is expanding its Japan-based network of independent pharmacovigilance (PV), Good Vigilance Practice (GVP) and Good Post-marketing Study Practice (GPSP) auditors. We support pharmaceutical and biotechnology clients with project-based audits and quality assessments across Japan, including sponsor/affiliate functions, outsourced safety vendors and post-marketing activities.

We welcome proven lead auditors and experienced co-auditors, including quality professionals who have performed structured PV audits or documented GPSP/PMS self-inspections. Assignments are matched to your actual specialism, location and availability; no single consultant is expected to cover every area. This is an independent consulting opportunity, not a permanent position or a promise of continuous work.

WHY WORK WITH US

• Use your Japan PV/PMS expertise on a variety of clearly scoped audits, from local vendor operations to regional and global safety-system assessments.
• Be considered for work aligned with your specialist audit experience, preferred working arrangements and domestic travel availability.
• Work with ProPharma audit coordinators, technical reviewers and life-sciences clients to strengthen patient-safety oversight and regulatory readiness.

EXAMPLES OF AUDIT SPECIALISMS

• We are interested in demonstrated experience in one or more of the following areas; the individual project determines the precise technical requirements.
• PV / GVP vendor audits: adverse-event intake at medical information or safety call centres, case-processing providers, CROs, market-research agencies, patient-support programmes and other outsourced services.
• Individual case safety reporting (ICSR): intake and triage, seriousness assessment, coding, follow-up, reconciliation, data quality, submission timelines and safety-database controls.
• Japan GPSP / post-marketing surveillance (PMS): use-results surveys, observational or database studies, monitoring, data management, service-provider oversight and documented self-inspection activities.
• PV quality systems and affiliate audits: SOPs, training, deviation/CAPA, local safety governance, partner/vendor oversight, quality agreements and safety-data exchange agreements (SDEAs).
• Broader safety processes: literature surveillance, signal detection, risk-management plans (RMPs), aggregate safety reporting and periodic safety review, where within your expertise.
• Inspection readiness and specialist reviews: PMDA-facing readiness, process gap assessments, case-file traceability, safety-system data integrity, CAPA effectiveness and follow-up audits.

WHAT YOU WILL DO

• Plan and conduct, or substantively support, risk-based PV/GVP/GPSP audits or scoped quality assessments against the applicable Japan requirements, client procedures and agreed audit criteria.
• Review relevant pre-audit documents, safety records and vendor arrangements; prepare audit agendas, interview questions and evidence requests.
• Interview Japanese site, affiliate and vendor personnel; evaluate controls, data flows, oversight, escalation and documented compliance evidence.
• Draft clear, evidence-based audit observations and timely reports in the agreed language; explain risk and recommended corrective actions without overstating conclusions.
• Support audit debriefs and agreed follow-up, including review of root causes, corrective and preventive actions (CAPA) and the adequacy of remediation.

REQUIRED EXPERIENCE & CAPABILITIES

• Substantive hands-on PV quality audit, GVP vendor/process audit, GPSP/PMS self-inspection or closely related regulated quality-assessment experience, with evidence of your own audit role; routine PV operations alone are not sufficient.
• Demonstrable expertise in at least one specialist area above and the ability to assess objective evidence, identify gaps and contribute to structured findings and reports.
• Working knowledge of the applicable Japanese GVP and/or GPSP framework and relevant PMDA/MHLW expectations for the particular audit scope.
• Native-level Japanese for detailed interviews, stakeholder discussions and review of Japanese-language safety and post-marketing records.
• Based in Japan and able to undertake agreed on-site work and domestic travel when the assignment requires it; able to maintain confidentiality, impartiality and professional documentation standards.

ADDITIONAL EXPERIENCE WE VALUE

• An audit log showing recent PV/GVP/GPSP assignments, roles (lead/co-auditor), vendor or process type, geography and reporting language.
• Direct audits of call centres, case-processing operations, market-research providers, PMS monitoring/data-management vendors or multiple Japanese sites.
• Independent lead-auditor experience, global PV/QMS systems, business-partner audits, safety agreements, PMDA inspection preparation or CAPA effectiveness checks.
• Professional English for international coordination and English-language audit reports; EU GVP, ICH E2 and/or FDA safety-reporting familiarity where relevant.
• Previous freelance consulting, remote audit delivery or working with international audit teams and sponsor SOPs.

ENGAGEMENT DETAILS

Each project is separately agreed. Work may include preparation, one or more on-site or remote audit days, report drafting and follow-up; multi-site work may involve travel within Japan. Scope, fees, expected hours, report language, travel/expense arrangements and deliverables are confirmed before acceptance. Selection depends on technical fit, availability, client approval and contractor onboarding. No minimum number of projects or ongoing assignment volume is guaranteed.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***