Senior Safety Manager

Location:  Tokyo, Japan Category: Safety & Pharmacovigilance

Description

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
  • 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
  • Responsible for oversight of Risk Management Plans
  • 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. 
  • Oversight and monitoring for self-inspections conducted for pharmacovigilance
  • 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 life sciences or nursing/pharmacy qualification (preferred)

 

 

EXPERIENCE

  • Minimum of 8+ years previous pharmacovigilance experience in Japan and at least 8+ 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 to a team 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

 

WORK ENVIRONMENT / PHYSICAL DEMANDS

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

 

EQUIPMENT

Computer work, utilizing common software programs

 

CONTACTS

Pharmacovigilance, Global Medical Affairs, Commercial, Legal, GVP Compliance, Regulatory Affairs

 

 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.