Job Information
J&J Family of Companies Japan Country Safety Officer Associate manager in Tokyo, Japan
Japan Country Safety Officer Associate manager - 2407021560W
Description
What You Will Do
Japan Country Safety Officer is responsible for the coordination and execution of post-marketing safety management activities for JNTL Consumer health K.K.
to ensure that all of local regulatory requirements, Kenvue and ethical responsibilities are met.
Local official company name in Japan.
Key Responsibilities
Support the transition to Global Safety database.
Ensure mechanisms in place to collect and receive adverse events from the various source, in partnership with the customer call center and other functions involved.
Lead the discussion to ensure that local processes and systems are in place for tracking, processing, submission with new Global Safety Database and conducting follow up for Adverse Events (AE) and other safety information. The scope of the product is OTC-drug, Medical device, Cosmetics and Quasi-drug.
Lead the discussion of case assessment with global medical safety to provide consistent approarch.
Ensure all local PV quality documents are reviewed and updated to align with global/local requirement.
Oversight external vendor for local safety management.
Supporting in the responses to safety-related health authority queries in the territory if applicable.
Escalate compliance issues in a timely manner to Country safety head to ensure appropriate mitigation is implemented.
Advise the local business on the PV impact of local organized data collection programs.
Identify issue and problem and have communication with global stakeholders to solve the problems.
Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
Ensure local/global medical or scientific literatures are reviewed to identify possible adverse events.
Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
Ensure all required documents related to PV departmental activities are retained according to regulatory requirements.
Ensure PV inspection/audit readiness at the affiliate level at all times.
Maintain awareness of local PV legislation and guidelines.
Work collaboratively with other functions and regional affiliates to ensure implementation of new company policies and regulatory requirements.
Qualifications
What We Are Looking For
Required Qualifications
34 years’ experience working in the pharmaceutical industry is strongly preferred; PV related experience or global safety data base experience is an advantage.
Business level English: listening, writing, speaking
Ability to work independently but collaboratively in a matrix organization
Knowledge of PV regulations
Demonstrated attention to detail
Excellent written and spoken communication and presentation skills.
Desired Qualifications
Medical, pharmacy or life-sciences degree (or equivalent) is preferred.
Experience using global safety database desirable
What’s In It For You
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location Asia Pacific-Japan-Tokyo-To-Chiyoda
Job Function Administration
Req ID: 2407021560W
J&J Family of Companies
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