Position Summary
The Manager/Senior Manager, Safety will support pharmacovigilance (PV), quality control, and vendor oversight activities with respect to the individual case safety report (ICSR) management process at Rakuten Medical.
Key Duties and Responsibilities
- Support ICSR case processing or oversight of vendor activities within the safety database and other systems according to company policies and procedures
- Create Risk Management Plans, Aggregate Reports (e.g. Periodic Safety Update Report)
- Support management of GVP SOP, and other key PV regulatory documents
- Participate in the development and implementation of process and procedures to ensure ICSR case processing complies with health authority guidance and regulations (PMDA)
- Manage departmental and company training requirements
- Support internal audits and inspections to ensure accurate information is provided as needed
- Lead and/or address quality control activities such as deviation identification, documentation, and Corrective Action Preventative Actions (CAPA) management related to the ICSR process
- Responsible for interdepartmental collaboration, such as, but not limited to Quality and Regulatory to ensure alignment on procedures, shared deliverables, and goals
- Collaborate with other functions to create aggregated reports and safety documents to support risk management such as drug safety reports, due diligence, approval filing activities, SOPs, and policies
- Participate in the Project team such as Clinical trial, Device development and support other functions to proceed the project
- Manage safety activities in local clinical studies
- Other duties as assigned
Desired Education, Skills and Experience
- Bachelor’s degree or higher in a life science related field or Health Care Professional (Nurse, Pharmacist, or physician) preferred
- 3+ years of experience of pharmacovigilance in the pharmaceutical or medical device Industry
- Strong organizational skills and ability to meet deadlines
- Working knowledge and experience of ICSR processing preferred
- Regulatory knowledge is preferable (ICH Guidelines, FDA safety regulations, EMA regulations, and other applicable regulatory guidance documents)
- Exceptional self-management ability
- Business level English (Writing, Reading, and Speaking)
What We Do
Rakuten Medical, Inc. is a global clinical stage biotechnology company developing and commercializing precision, cell-targeting investigational therapies on its AlluminoxTM platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Alluminox therapies have not yet been approved as safe or effective by any regulatory authority. The company’s first drug developed on the Alluminox platform, ASP-1929, has received approval from the Japanese Ministry of Health, Labour, and Welfare, and is currently the subject of a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. The company has locations in 5 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, and Switzerland. For more information, visit www.rakuten-med.com.
