For Current Gilead Employees and Contractors:

　　Please log onto your Internal Career Site to apply for this job.

　　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.

　　We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

　　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. Join Gilead and help create possible, together.

　　Job Description

　　Manager - Sr. Manager, Benefit-Risk Management,

　　Japan Patient Safety (J-PS)

　　Specific Responsibilities:

　　Essential Functions:

　　Job Description

　　Specific responsibilities

　　Serves as or contributes to a member of the Benefit-Risk Management, in developing content and strategy.

　　Provides support to Benefit-Risk Management, Associate Director - Director, directly.

　　Oversees and ensures successful completion of all assigned activities and projects.

　　Well understands all activities and projects performed in responsible therapeutic areas, products, and projects.

　　Leads assigned topics and/or reviews: literature review for ICSRs screening and other report types including Foreign Safety Measure (FSM) report and Japan Research Report (RR) criteria.

　　Complies with all regulatory requirements of Pharmacovigilance regulations globally from competent authorities; maintains confidentiality; meets all safety reporting deadlines.

　　Signal detection and authorship of signal work-up documents in collaboration with relevant contact at global Therapeutic Areas members.

　　Appropriate input and support for safety descriptions in Japanese Package Insert (J-PI) and associated supporting documentation.

　　Authorship of aggregate safety reports (e.g., J-PSR, Non-serious unlisted line-listing reports (NSUL), Periodic Infection Reports, J-DSURs).

　　Authorship of responses to regulatory agency safety enquiries (RtQ).

　　Contributes to safety analyses in Regulatory submissions (e.g., Business License Applications and Renewals, Marketing Authorization Application (MAAs), New Drug Application (NDAs) in collaboration with relevant global PS functions and local project members.

　　Reviews and inputs appropriately clinical trial protocols, investigator brochures (IB), informed consent forms (ICF), final study reports (FSR), and other study related documents on team review or RDMS review.

　　Oversights CRO activities for the Benefit-Risk Management and/or Strategic Operations regarding relevant safety information handling and resolve any issues ensuring to comply with safety requirements.

　　Authorship of protocol, lead sets-up, and oversight of Early Post-marketing Phase Vigilance (EPPV) activities. Responsible to develop interim/final EPPV reports.

　　Collaborates with PMS manager/study lead for timely execution of PMS activities as they relate to single case management to comply with local GPSP requirements.

　　Support Safety Manager in Japan to comply with J-GVP requirements, under the supervision of Director, Benefit-Risk Management. Essential Duties and Job Functions:

　　Participates on and may lead various cross-functional teams, involving interaction with Gilead staff within and outside of J-PS department, to convey and acquire safety information internally and externally.

　　Contributes to the Benefit-Risk Management and or Strategic Operations teams for communicating and ensuring that all customers are fully informed and knowledgeable of project activities and their status.

　　Contributes to audits/inspections of systems and procedures to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to findings relevant to assigned responsibilities.

　　Participates in both internal and external educational initiatives.

　　May contribute in vender oversight activities in the J-PS teams.

　　Well understands and follows global and long-term goals for responsible therapeutic areas, products, and projects, in collaboration with Associate Director - Director, Benefit-Risk Management, considering and providing support for the strategic goals of the organization.

　　Demonstrates independent thought and initiative in the preparation and completion of projects.

　　Recognized as an expert on pharmacovigilance regulations, aggregate safety reports, internal risk management plans, signal detection, clinical trials, and clinical development within J-PS and by external departments.

　　Presents results and findings and discusses processes in formal settings with consideration of the impact on processes within and outside of J-PS, under the supervision of Associate Director - Director, Benefit-Risk Management.

　　Knowledge, Experience & Skills:

　　Essential: Desirable:

　　Basic Qualifications

　　Knowledge, Experience and Skills:

　　Note : The following represent common education and experience but not mandatory requirements.

　　Demonstrates proficiency in verbal and written communication, including Microsoft Excel, Word, and Power Point.

　　Demonstrates excellent attention to detail, teamwork, and initiative; maintains confidentiality; maintains meticulous attention to project deadlines.

　　Demonstrates ability to assess complex data sets and understand the safety/medical implications.

　　Demonstrates good understanding of pharmacovigilance and observational studies used in pharmacoepidemiology.

　　Typically requires a degree (e.g., BS, BA, MSc, or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline with demonstrated experience with the responsibilities, deliverables, and skills required for this level.

　　Excellent knowledge of pharmacovigilance regulations regarding periodic safety reports, internal risk management plans, signal detection, clinical development and operations.

　　Require experiences (5+ years, preferred) in pharmacovigilance/PMS areas.

　　For Current Gilead Employees and Contractors:

　　Please log onto your Internal Career Site to apply for this job.

　　Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

　　Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

　　The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.