Head of Pharmacovigilance (PV), Japan

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Join our team as a working manager responsible for PV activities in Japan!

Your role will include ensuring compliance with local regulations, global standards, and Baxter policies. Additionally, you will act as Safety Control Manager for Baxter Japan.

Align with safety regulations to lead all aspects of medical product safety in Japan and take vital action, such as implementing risk minimization activities. Understand and follow Baxter's Pharmacovigilance Quality systems and policies. Bring together local safety information in the Global Pharmacovigilance safety databases and submit it to regulatory authorities within the required timelines.

Establish effective communication with country Medical Affairs, Regulatory, Clinical, Quality, Business Units, Legal, etc., to incorporate Pharmacovigilance input into country-level planning for products throughout their lifecycle. Share any compliance concerns or provide feedback on local PV activities to Regional Director PV APAC.

Crucial Duties and Responsibilities

Local Safety Control Manager

• In the capacity of Local Safety Manager, have oversight of all pharmacovigilance activities as per applicable local legislation.

Safety Risk Management Activities

• Identify the local regulator requirements for RMP (Risk Management Plan) submissions, communicate the requirements to the distributed team, and provide local inputs as needed. Implement local risk minimization measures as appropriate.
• Conduct surveillance for potential safety issues (e.g., similar adverse events clustered together or multiple cases for one batch received rapidly) and bring up any concerns following protocols.

PV Quality Systems

• Have a detailed understanding of and align with the Baxter Pharmacovigilance Quality systems and policies.
• Maintain experienced knowledge and awareness of local pharmacovigilance regulations and implement as appropriate.
• Ensure adequate understanding of audit and inspection preparation and readiness.
• Ensure understanding of the CAPA (Corrective and Preventive Actions) process. Responsible for performing CAPA activities as per identified roles.
• Ensure compliance with procedures for document management retention and archiving.
• Understand and implement the document organisational change process and act as SME (Subject Matter Expert) for local procedures.
• Ensure all training requirements for the role are met.
• Identify appropriate collaborators and ensure they are trained on PV reporting requirements/procedures.
• Build alignment and collaboration with local Regulatory Affairs, Medical Affairs, Clinical Operations, Quality Assurance, and Business Unit teams.
• Communicate effectively all relevant safety information and PV related compliance concerns with the APAC PV Regional Director and PV Compliance.
• Ensure adherence and appropriate implementation of the BCP (Business Continuity Plan).

Case Intake

• Coordinate the case processing activities of local PV personnel to ensure alignment with Baxter procedures and regulatory requirements.

Regulatory Submissions

• Maintain expert knowledge of the regulatory reporting requirements and ensure the reporting rules in the system are aligned to the local reporting requirements.
• Manage the process for expedited submission of domestic AEs to local authorities with translation of documents as the need arises. Track submissions in the Pharmacovigilance safety database and archive all submission records.
• Respond to submission-related queries from the local regulatory authorities and archive all regulatory-related correspondence.
• Coordinate foreign case submission to ensure compliance with regulations and Baxter requirements.

Other Responsibilities

• Collaborate with local Regulatory Affairs to maintain a calendar of local PSUR requirements. Communicate and meet these requirements with the Distributed team.
• Provide the appropriate local inputs for the EU PSMF (Pharmacovigilance Systems Master File) sections.
• Learn about local AE report rules, get info from GPS, and send reports to authorities as needed.

Team Management

• Establish and supervise budgets and forecasts.
• Lead and support local Pharmacovigilance personnel.
• Handle the recruitment, mentoring, and growth of new PV personnel.
• Provide feedback and regular reporting to Regional Director PV APAC.
• As the need arises, participate in the Japan leadership team (JLT) meeting or other meetings as the local function head and collaborate with applicable departments.

Vendor/Third party Management

• Verify that the service provider is qualified before the service starts.
• Write the Statement of Work (SOW) and/or contract as per J-GVP and Baxter requirements.
• Develop consistent communication with the Person Responsible for Implementation of Safety Management at the contractor company to ensure outsourced work is accurately and efficiently handled.
• Supervise the performance of outsourced PV activities
• If the improvement is necessary, guide the contractor to take vital actions.

Qualification

• Authoritative knowledge of Pharmacovigilance relevant local regulations and sound knowledge of international relevant regulations and standards (e.g., GVP and Green Book).
• Solid understanding of the clinical drug development processes (GCP) and PMS implementation processes (GPSP).
• Familiarity with MAH (Marketing Authorization Holder) license transfer, re-examination procedure, GVP inspection by Tokyo metropolitan government, and PV safety database maintenance, or equivalent experience.
• Good communication and problem-solving skills.
• Ability to collaborate with different functions to effect change, including Regulatory Affairs, Quality Assurance, Distribution, R&D, Manufacturing, Marketing, and Sales.
• Ability to work well in matrix, and regional/virtual team environment.
• Good English and Japanese writing skills, including but not limited to translations of documents from Japanese to English and vice versa.
• Proficient in both written and spoken English.

Education and Experience

• Proven experience in Pharmacovigilance (required).
• Track record of managerial experience in small-medium size people team.
• License of doctor or Pharmacist (not required, desirable).
• Work experience in a multinational Company with international exposure would be a plus.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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