Job Description

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

This role is responsible to act as Affiliate Head of Patient Safety (AHoPS) of Japan, who is the local PV strategic partner, responsible for providing pharmacovigilance expertise, ensuring patient centric focus, influencing internally and externally, pro-active decision making as well as cross functional collaboration to provide local insights and the patient perspective to the global team. This role is a critical point of contact on all safety matters for internal (e.g., Clinical, Regulatory Affairs, Quality, Medical Affairs, Marketing and Commercial functions) and external (e.g., MHLW/PMDA/Tokyo Metropolitan Government and business partner companies) stakeholders.

This position is also responsible to fulfil the mandatory local regulatory role as “Safety Manager (ANSEKI)” under the requirement of Japanese Good Vigilance Practice (J-GVP).

This position oversees the end-to-end process of individual safety case reports (ICSRs), periodic safety update reports, and relevant benefit-risk management activities e.g., Japan Risk Management Plan (RMP), local signal monitoring, ad-hoc PV planning and Risk Minimization Measures (aRMM) complying with both global and Japanese regulatory requirements throughout the clinical development, new drug application (J-NDA)/approval and through the post-marketing lifecycle management phases of Gilead’s innovative investigational/marketed products (covering both pharmaceutical products and regenerative medicine products).

This position reports directly to the Vice-President, PharmacoVigilance Governance & Affiliates (PVG&A), EU QPPV at Gilead Sciences Inc., who is part of the Patient Safety departmental Leadership Team.

Job Responsibilities:

• Provide the Vision and Direction for the Patient Safety - Japan organization in Japan in line with global strategy of Patient Safety, objectives of the Regulatory/Safety/Quality (RSQ) within R&D, and Gilead Core Values.
• Responsible for team development including the next generation of safety leaders in Patient Safety Japan; ensuring that staff appropriately trained to meet local needs; monitoring and optimizing resources and budget to deliver the portfolio and maintaining marketed products.
• Represent Patient Safety at local leadership meetings within Gilead Japan, establishing strong cross-functional relationships/network in the local organization (e.g., Clinical, Regulatory Affairs, Quality, Medical Affairs, Marketing and Commercial functions), and actively participating in internal and external networking.
• Provide safety strategic input to the relevant functions in Japan and global to contribute the planning and execution of product development and product lifecycle management.
• Provide leadership and local decision making in collaboration with global Patient Safety on communication of safety information to external and internal stakeholders.
• Ensure that all safety report submissions to local Health Authorities (e.g., ICSRs, Periodic Safety Update Reports) and to medical institutions (e.g., for EC/IRBs) meet local requirements, complying with Gilead global procedural documents.
• Lead the interaction and communication regarding safety related matters with the local HAs and act as the main point of contact for the local Health Authorities, working proactively to build and maintain contacts with relevant local Health Authority departments.
• Collaborate as Safety Manager-ANSEKI closely with the General Marketing Compliance Officer-SOSEKI, QA Manager-HINSEKI, and other senior management, acting as strategic partner.
• Ensure that Gilead fulfills all safety requirements linked to the Pharmaceutical Business License and Marketing Authorization/local license as Marketing Authorization Holder of Drug Products and Regenerative Medicine Products.
• Ensure compliance with the relevant laws and regulations and Gilead global procedural documents for by leading inspection readiness activities.
• Initiate and/or contribute to local and / or global process improvements which have a significant impact on process/costs and quality of deliverables.
• Closely monitor and communicate to relevant global and local stakeholders, relevant external policy and safety regulation changes (Japan), maintaining up to date knowledge on safety requirements and guidance, anticipating potential changes in safety requirements that could impact on safety operations and monitoring competitor information with obtaining benchmarking data.
• Plays an active role in safety related industry organizations building recognition as a thought leader, as required locally if appropriate.

Minimum Education and Basic Qualifications:

• Typically requires a PhD or MSc degree in Pharmaceutical Sciences or equivalent discipline and minimum 10 years of relevant experience in Patient Safety/Pharmacovigilance area in healthcare companies.
• Registered Pharmacist is preferred.
• Extensive experience in and understanding of role of Patient Safety/Pharmacovigilance and safety related regulatory requirements in Pharmaceutical/Biotech Industry including international requirements, e.g. ICH, FDA and EMA requirements and national requirements, e.g. MHLW&PMDA requirements etc. and have insights of current trends.
• Strong influencing and negotiating skills. Must be capable of developing and implementing risk minimization strategy and of managing complex negotiations with senior representatives in local Regulatory Authorities.
• Demonstrates strong leadership skills with a sphere of influence locally and globally, internally and externally and cross-functionally.
• Previous people management experience is required and direct experience working as safety Subject Matter Experts (SME) with internal and external stakeholders (including PMDA) is essential.
• Excellent decision-making skills, makes important decisions that impact the department and ensures they are proactively and appropriately communicated.
• Strong verbal, written, organization skills and interpersonal communication skills in Japanese and English.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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