- 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.
- 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.
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Manager~Sr. Manager, Patient Safety - Tokyo, 日本 - Gilead Sciences K.K.
説明
Description
Specific responsibilities
Knowledge, Experience & Skills:
Essential: Desirable:
Basic Qualifications
Knowledge, Experience and Skills:
Note: The following represent common education and experience but not mandatory requirements.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
TokyoのManager~Sr. Manager, Patient Safety専門家のユーザー
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Hesham Taniguchi
Senior Consultant Engineer, Dr.Eng., P.E.
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Freddie Ansley
Dependable, detail oriented seeking employment