Career Category
SafetyJob Description
Group Purpose
Facilitate patient access to Amgen products in Japan through the following: compliance with applicable local regulations; development and maintenance of local business processes in pharmacovigilance (PV) and post marketing surveillance (PMS), integrated in relevant Amgen processes; development and execution of Japan risk management plan (J-RMP); assessment of safety data in Japan; provision of safety expertise; leading and collaborating on post marketing surveillance (PMS) activities; interface with regulatory agencies and industry organization; alignment with key cross-functional partners and business partners; continuous improvement of business processes
Job Summary
As part of the Japan Safety organization at Amgen KK (Amgen Japan), the Japan Safety PV Sr Assoc is responsible for: performing PV activities under the guidance of Japan Safety PV Sr Manager, Japan Safety PV Team Manager, or Japan Safety PV Manager: contributing to the local safety function in interactions with other functions within Amgen KK, staff members in Global Patient Safety, business partners and external health care professionals, to achieve Safety objectives; helping ensure compliant and efficient performance of local safety activities based on sound knowledge of local legislative requirements and practice, Amgen policies and procedures; and participating in exchange of safety information with stakeholders (Amgen, Amgen KK, partners, and external; local, regional, and global) to support informed understanding of product safety issues.
This position reports to Japan Safety PV Sr Mgr, Japan Safety PV Manager, or Japan Safety PV Manager
Key Activities
Perform the following tasks, under the direction and guidance of the Japan Safety PV Sr Mgr, Japan Safety PV Team Manager, and/or Japan Safety PV Mgr:
General:
- Execute safety (PV) processes for Amgen products
- Represent the Safety function on local product team(s) and joint product team(s) and Joint product teams(s)
- Ensure safety compliance review and quality of safety part of CTN and NDA dossiers in Japan
- Contribute to the creation and improvement of local business processes and system infrastructure for safety information collection and management
Safety Reporting and Safety Database:
- Contribute to Safety Database conventions development and maintain current awareness of those conventions
- Prepare the local periodic aggregate safety reports (e.g., J-DSUR, J-PBRER)
- Perform assigned tasks ICSR handling workflow and the preparation of Japan-specific safety reports
Risk management and Risk communication:
- Collaborate with cross-functional stakeholders on risk management planning and local risk minimization actions
Compliance and Regulatory:
- Advocate safety compliance
- Prepare for and participate in regulatory inspections by Regulatory Authorities
Training and Other Cross-functional Activities:
- Train Amgen KK and Amgen employees on safety reporting needs in Japan
Knowledge and Skills
- Experience in directly related to safety areas including PV regulations
- English language proficiency (business discussions, reading, and writing)
- General understanding of industry practices and standards
- Experience with MS Word, Excel, PowerPoint, and Outlook
Education & Experience (Basic)
- Not applicable for positions in Japan
Education & Experience (Preferred)
- Master's degree and 1 year of directly related experience
- OR
- Bachelor's degree and 3 years of directly related experience
-
Japan - Tokyo Amgen ￥6,500,000 - ￥10,300,000 per yearFacilitate patient access to Amgen products in Japan through the following: compliance with applicable local regulations; development and maintenance of local business processes in pharmacovigilance (PV) and post marketing surveillance (PMS), integrated in relevant Amgen processe ...
-
Tokyo, Tokyo Amgen ￥3,000,000 - ￥6,000,000 per yearThis position reports to Japan Safety PV Sr Mgr, Japan Safety PV Manager, or Japan Safety PV Manager and is responsible for performing safety activities under the guidance of senior managers. · ...
-
Tokyo Amgen Full time￥4,000,000 - ￥6,000,000 per yearAs part of the Japan Safety organization at Amgen KK (Amgen Japan), the Japan Safety PV Sr Assoc is responsible for performing PV activities under the guidance of Japan Safety PV Sr Manager, Japan Safety PV Team Manager, or Japan Safety PV Manager: contributing to the local safet ...
-
Tokyo, Tokyo Planet Pharma ￥400,000 - ￥800,000 per yearThe Pharmacovigilance (PV) Associate is responsible for supporting the pharmacovigilance system to ensure compliance with both local and global regulatory requirements. · Adverse Event (AE) Case Management · Receive, review, and process adverse event reports from various sources ...
-
Tokyo ICON plc ￥4,000 - ￥8,000 per yearWe are seeking a Pharmacovigilance Reporting Associate to join our diverse and dynamic team. · Preparing and reviewing safety reports. · Collecting and analyzing adverse event data. · ...
-
Tokyo Worldwide Clinical Trials ￥4,500,000 - ￥6,300,000 per yearPharmacovigilance is the gateway to ensuring drug safety. The Pharmacovigilance team at Worldwide Clinical Trials comprises a dynamic group of individuals with extensive experience within the Drug Safety world. They review safety events from all over the world and work with clien ...
-
Tokyo, Tokyo Nextrials, Inc. ￥2,000,000 - ￥5,000,000 per yearWe are seeking a Pharmacovigilance Reporting Associate to join our diverse team! As a Pharmacovigilance Reporting Associate at ICON you will prepare accurate safety reports related to clinical trials & post-marketing activities. ...
-
Tokyo ICON plc ￥6,000,000 - ￥9,000,000 per year· We're proud to foster an inclusive environment driving innovation and excellence, · a Pharmacovigilance Reporting Associate is responsible for the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. ...
-
Tokyo Worldwide Clinical Trials ￥900,000 - ￥1,200,000 per yearWe are looking for others who value this same pursuit. We believe everyone plays an important role in making a world of difference for patients and their caregivers. · Author Safety Management Plan for assigned studies · Attend internal and client meetings as appropriate · Attend ...
-
Tokyo ICON plc Full time￥4,032,000 - ￥6,048,000 per yearICON plc is seeking a Pharmacovigilance Reporting Associate to join its diverse and dynamic team. · ...
-
Tokyo, Japan PrimeVigilance ￥400,000 - ￥800,000 per yearWe are PrimeVigilance, a specialized mid-size pharmacovigilance service provider established in 2008. We operate globally and provide services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. · We cover all therapy areas including medical devi ...
-
Tokyo, Japan Crimson Interactive ￥1,500,000 - ￥3,000,000 per yearCrimson Interactive is an ISO-certified organization providing Japanese and English language solutions to customers globally. We are looking for a Business Associate - Client Services to interact with clients and provide guidance and information as per client requirements. · Addr ...
-
JP - Tokyo Elanco ￥560,000 - ￥1,200,000 per yearThis role will serve as an HR Business Partner to provide HR partnership to Elanco Japan organization including contributing to business strategy, developing and executing an aligned people strategy; designing and catalyzing implementation of relative people plans/initiatives; an ...
-
Tokyo Elanco ￥80,000 - ￥160,000 per yearWe are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. We believe that diversity is the driving force behind innovation, creativity, and overall business success. · ...
-
Tokyo Alexander Chapman ￥600,000 - ￥1,800,000 per yearConduct market research and financial analysis to identify and evaluate investment opportunities across biotech, medtech, and healthcare services. Build and maintain detailed financial models to assess valuation, deal structures, and return scenarios. Support due diligence proces ...
-
Tokyo, Tokyo Amgen ￥5,000,000 - ￥8,000,000 per yearProvide balanced, accurate, and scientific medical/pharmaceutical information related to Amgen K.K. products and therapeutic areas (TAs), in response to unsolicited medical inquiries, in compliance with global SOPs and local regulations. · Provide balanced, accurate, and scientif ...
-
Tokyo Capital Group ￥900,000 - ￥1,200,000 per yearAs part of Capital Group growth plan in Europe and Asia, we are expanding our TKO Operation team in our Tokyo Office. The International Fund Admin Associate Sr demonstrates an advanced level of knowledge in the assigned area and works under supervision only as needed. · Fund acco ...
-
Tokyo Vena Group ￥8,000,000 - ￥12,000,000 per yearThe primary objective of this role is to strategically enhance the prospects of securing Power Purchase Agreements (PPAs) for hybrid plants as the company transitions towards more Corporate Power Purchase Agreements (CPPAs). Achieving this will require seamless and comprehensive ...
-
Tokyo Vena Group ￥6,300,000 - ￥10,560,000 per yearThe position of Sr. Associate, Wind Project Engineer encompasses a wide range of tasks related to wind energy projects including site assessment, wind resource analysis, project development, construction and operation. · Minimum 5 years' experience in engineer or assessment in wi ...
-
Tokyo Gilead Sciences ￥6,000,000 - ￥12,000,000 per yearWe believe every employee deserves a great leader. · This position reports to the Therapeutic Area (TA) Lead for HIV & COVID-19 · ...
-
Roppongi, Tokyo Uber ￥400,000 - ￥800,000 per yearAs a member of the Uber Delivery Commercial Training and Enablement team, you will be responsible for implementing commercial training & enablement programs for our OFD commercial team members. · Manage the implementation of key training enablement programs for sales and account ...
