Pharmacovigilance (PV) Director, Japan
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Job Summary
Job Description Summary
The Pharmacovigilance (PV) Director & Anseki is a senior leadership role required under the Japanese Pharmaceutical and Medical Device Act (PMD Act) to ensure the safe and compliant commercialization of pharmaceutical products in Japan. This position provides strategic oversight of all Japan PV activities ensures full compliance with J GVP GPSP and other applicable regulations and serves as a key interface with PMDA. The Director leads Japans PV system manages and develops the Japan PV team collaborates closely with global safety teams and drives operational excellence across post marketing safety activities.GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world.
Job Description
Key Responsibilities
- Serve as the Anseki (Safety Management Supervisor) in accordance with JGVP ensuring full compliance with Japan PV regulatory requirements.
- Act as a primary point of contact for PMDA and MHLW on safetyrelated matters including inquiries inspections and postmarketing safety commitments.
- Ensure timely and accurate expedited ICSR reporting periodic safety reporting risk management plan (RMP/JRMP) development and safetyrelated labeling updates.
- Establish maintain and continuously improve a robust and inspectionready PV system that enables detection collection processing evaluation and reporting of adverse events (using safety database and other related tools).
- Oversee local literature surveillance safety data review and compliance with all Japanspecific reporting requirements.
- Ensure a comprehensive PV training program for all relevant staff in Japan
- Lead inspection readiness activities and manage PMDA inspections internal audits and vendor audits including CAPA development and followup.
- Develop maintain and update SOPs work instructions and controlled documents related to postmarketing safety activities.
- Monitor evolving PV regulations and proactively communicate requirements and impact assessments to internal stakeholders.
- Partner with senior leaders in PV Medical Affairs Regulatory Affairs Quality and Commercial to ensure aligned safety strategies across the product lifecycle.
- Collaborate with global PV teams to ensure consistency of processes alignment with global safety strategy and effective implementation of global systems and tools.
- Support crossfunctional initiatives such as labeling updates postmarketing studies and safety governance meetings.
- Manage and oversee local vendors performing PV activities ensuring compliance with contractual obligations KPIs and quality standards.
- Ensure appropriate oversight of distributors partners and third parties who may receive safety information.
- Lead mentor and develop Japanbased PV team members ensuring clear role expectations effective performance management and continued professional growth.
Qualifications / Requirements
- Minimum 710 years of pharmacovigilance experience in the pharmaceutical industry including significant exposure to Japan PV regulations (JGVP GPSP).
- Demonstrated experience interacting with PMDA and supporting regulatory inspections.
- Strong understanding of global PV regulations (ICH GVP) and how they interface with Japan requirements.
- Safety Database experience (such as Argus-J)
- Proven ability to operate effectively in a matrixed global organization with strong crossfunctional and crossregional communication skills.
- Excellent written and verbal communication skills in Japanese and English.
- Strong leadership problemsolving and decisionmaking capabilities.
- Peoplemanagement experience including the ability to mentor develop and motivate team members is preferred.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
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Additional Information
Relocation Assistance Provided: No
Required Experience:
Director
Key Skills
- Fundraising
- Management Experience
- Coaching
- Analysis Skills
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Mentoring
- Public Speaking
- negotiation
- Supervising Experience
About Company
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients
