PV & PMS Manager Associate

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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This position is responsible for leading all local pharmacovigilance (PV) activities as the designated representative of Ipsen Japan.

• Ensures the appropriate deployment maintenance and continuous improvement of the local PV system.
• Ensures that all PV and PMS processes within the affiliate remain compliant up to date and inspection-ready and acts as the primary liaison with Global Patient Safety (GPS).
• Serves as the key point of contact for medical activities within the affiliate ensuring appropriate coordination and alignment with internal stakeholders.
• Responsible for establishing implementing and maintaining the local PV/PMS framework in accordance with applicable Japanese regulations and serves as the National PV/PMS contact.
• Ensures that PV/PMS documentation systems and procedures are maintained in a state of continuous compliance and readiness in collaboration with GPS and Medical Affairs.
• Serves as the primary affiliate contact for observational and clinical study activities ensuring appropriate oversight and compliance with relevant standards and guidelines.

Main Responsibilities

PV Roles & Responsibilities

• Deliver all PV activities per local regulations and IPSEN global/local SOPs
• Act as the local PV contact for GPS.
• Ensure accurate and timely reporting/follow-up of AEs and special situations with translation and QC in place.
• Conduct literature review to collect AEs and identify safety signals escalate local signals or authority alerts.
• Compile monthly metrics perform weekly/monthly reconciliations for AEs and PQCs (internal and vendors).
• Provide PV oversight to Risk Management Plans ensure ARMMs are managed per requirements.
• Provide PV expertise across the business maintain a comprehensive local PV system.
• Partner with Quality for compliant handling of product complaints and AEs.
• Prepare/review aggregate and ad hoc PV reports within regulatory timelines as requested (under GPS/country leadership).
• Support Patient Support Programs and PDCS (training eligibility documentation Global Inventory updates).
• Monitor local regulatory requirements and inform QPPV Office and/or GRA of changes.
• Participate in affiliate/GPS meetings escalate safety/compliance/operational issues to GPS and local leadership.
• Set and review local reporting rules in the global safety database.
• Deliver all PV activities per PMD-Act and JGVP Ordinance and Ipsen policies/SOPs prepare/revise GVP-SOP.
• Ensure comprehensive JGVP system complete documentation and provide JGVP training.

PMS Roles & Responsibilities

• Prepare PMS system setup with Safety Manager GPS and related functions to enable launch readiness without hindrance.
• Deliver all PMS activities per PMD-Act and GPSP Ordinance and IPSEN policies/SOPs prepare/revise GPSP-SOP.
• Prepare/submit PMS plans implementation and results reports to regulatory authorities; prepare J-PSUR.
• Act as PMS contact to prepare protocol synopsis with ERGB stakeholders.
• Track monthly PMS progress and coordinate weekly/monthly with internal teams and vendors.
• Contribute to J-RMP with Safety Manager (GVP GPSP) and plan/execute PMS as PVP of RMP.
• Prepare re-examination application materials and reporting to authorities with Safety Manager.
• Ensure comprehensive GPSP system complete documentation and provide GPSP training.

Cross Functional / Oversight Role

• Liaise with distributors/partners and internal functions (Medical Affairs Medical Information Regulatory Affairs etc.) to maintain oversight of workflows.
• Demonstrate scientific and business expertise relevant to therapeutic areas and competitive landscape.
• Support MI teams to forward safety reports to GPS Case Processing Centre maintain knowledge of MI systems.
• Act as PV contact for local clinical trials; ensure timely safety collection/handling and reporting.
• Provide outcome reports to GPS and local management; oversee PV agreements and safety exchanges with partners.
• Collaborate with GRA on regional appendices/aggregate reports; coordinate with Global/Local MA on ongoing studies.
• Provide information to support PSMF maintenance.

Training Audit Inspection and CAPA Management

• Ensure regular audits of the local PV system document outcomes.
• Coordinate deviations and CAPAs track and implement corrective/preventive actions.
• Review local SOPs/Instructions for compliance with GVP global SOPs and local needs.
• Ensure timely archiving per IPSEN SOPs and regulations.
• Develop/update training programs; maintain up-to-date training records.
• Prepare for inspections and internal audits; participate and support responses to findings.
• Ensure a tested business continuity plan with GPS and country leadership.

Knowledge & Experience

Education / Certifications (Essential)

• Bachelors degree in Life Sciences Pharmacy Nursing or related field.

Education / Certifications (Preferred)

• Advanced degree (PharmD PhD MD) is an advantage.

Knowledge & Experience (Essential)

• 35 years in medical information and pharmacovigilance within pharma or related field.
• Knowledge of regulatory standards (GVP GPSP).

Knowledge & Experience (Preferred)

• Understanding of clinical trials and marketing authorization processes.
• Hands-on PMS experience.
• Experience with J-RMP development and/or re-examination submissions.

Languages (Essential)

• Japanese: Fluent
• English: Business level

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