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Senior Pharmacovigilance/Safety Manager

Location Yoyogi-sanyachō,Tokyo, 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. 

SUMMARY DESCRIPTION

The Sr. PV Manager will work in conjunction with BioMarin Pharmacovigilance (BPV) headquarters for activities related to pharmacovigilance in Japan to ensure that all safety activities are conducted in accordance with internal SOPs, work instructions and local health authority requirements

RESPONSIBILITIES

  • Responsible for the overall management of pharmacovigilance activities in Japan
  • Act as the Local PV contact for BioMarin Pharmacovigilance (BPV)
  • Ensure all pharmacovigilance activities are conducted in accordance with BPV Japan’s SOPs, Work Instruction and local regulatory requirements
  • Accountable for the development and continual improvement of pharmacovigilance processes and standard operating procedures for pharmacovigilance in Japan
  • Work in collaboration with Global Medical Affairs on PMS/PMCS activities
  • Provide Pharmacovigilance oversight to the delivery of J-Risk Management Plans in conjunction with the cross-functional team, as applicable
  • Provide Pharmacovigilance expertise to all areas of the business as required
  • Manage local audit/regulatory inspections and work closely with BPV leadership in the implementation of CAPAs following the audits/inspections
  • Assist and support inspection readiness.  Continuously identify compliance issues and implement corrective/preventative actions. 
  • Ensure that regular, documented self-audits of the local PV system are conducted
  • 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 in inspections and audits as needed
  • Line management for Japan pharmacovigilance staff.  Provide coaching and identify opportunities for continuous improvement and self-development to optimize performance.
  • Perform other activities as directed by Pharmacovigilance management

EDUCATION

Degree in health sciences (nursing/pharmacy) or life sciences is preferred

EXPERIENCE

  • Minimum of 5-8 years previous pharmacovigilance experience in Japan and at least 3-5 years previous management experience required
  • Effective communication skills in verbal and written English
  • Advanced knowledge of regulatory reporting requirements and international regulations (EU, US, and Japan) and the ability to interpret and apply applicable regulations to resolve issues
  • Strong leadership skills, communicates and demonstrates vision and commitment
  • Creative problem solving in a complex, process-focused environment
  • Ability to provide direction and influence peers appropriately
  • Strong organizational skills, detail oriented, ability to adapt to change
  • Demonstrates initiative and accountability
  • Ability to provide exceptional customer service and professional interactions with a variety of cross-functional colleagues
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

Yoyogi-sanyachō,Tokyo

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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