As part of the Japan Safety organization at Amgen Astellas BioPharma (AABP), the Japan Safety PV Mgr is responsible for:
- Representing the local safety function in interactions with Regulatory agencies 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.
- Participating in exchange of safety information with stakeholders to support informed understanding of product safety issues.
- This position reports to Japan Safety PV Sr Mgr.
Facilitate patient access to the 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).
- 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.
- Execute safety (PV) processes for the products
- Represent the Safety function on local product team(s) and joint product team(s)
- Ensure safety compliance review and quality of safety part of CTN and NDA dossiers in Japan
- Contribute to and facilitate the creation and improvement of local business processes and system infrastructure for safety information collection and management
Safety Reporting and Safety Database
- Facilitate Safety Database conventions development and maintain current awareness of those conventions
- Perform assigned tasks in the ICSR handling workflow and the preparation and submission of Japan-specific periodic safety reports
- Facilitate development of productivity and compliance metrics for AE processing
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
- Negotiate with local regulatory agency officials on safety related topics
Training and Other Cross-functional Activities
- Lead and educate safety associate for safety activities
- Develop Safety MOUs using Globally consistent formats
- Participate in global/regional/country safety meetings to share best practice