Safety Manager - Japan
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
- Participate in the collection and receipt of local adverse events from various sources.
- Perform tracking, processing and submission for adverse events and other safety information.
- Ensure all required PV regulatory reporting is performed in compliance with the local regulations.
- Ensure all pharmacovigilance activities are conducted in accordance with BPV Japan’s Standard Operating Procedures (SOPs), Work Instructions (WIs) and local regulatory requirements
- Ensure all required documents related to PV activities are retained according to local regulatory requirements and internal policies
- Support the development and periodic update of the local pharmacovigilance SOPs and WIs
- Support the development and continual improvement of pharmacovigilance processes and standard operating procedures for pharmacovigilance in Japan
- Work in collaboration with the Sr. Safety Manager and Global Medical Affairs on PMS/PMCS activities
- Perform pharmacovigilance training to internal colleagues as required
- Support local audit/regulatory inspections and work closely with the Sr. Safety Manager and BPV leadership in the implementation of CAPAs following the audits/inspections
- Escalate compliance issues in a timely manner to the Sr. Safety Manager and BPV leadership and support appropriate mitigation
- Support the conduct of periodic self-audits of the local PV system
- Perform regular review of local regulatory requirements and best practices and inform Global PV of any changes to local regulations that impact the local or global PV system
- Participate and support JNDA activities as needed
- Perform other activities as directed by Pharmacovigilance management
EDUCATION & EXPERIENCE
- Degree in health sciences (nursing/pharmacy) or life sciences is preferred
- Minimum of 7 years previous pharmacovigilance experience in Japan
- Effective communication skills in verbal and written English