Description
Kenvue is currently recruiting for:
Manager Japan Country Safety Officer
This position reports into Country Safety Head in Japan and is based at Tokyo Japan.

Who We Are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Dr.Ci:Labo®, NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.


What You Will Do
Understand local regulation and general case processing manner in Japan.
ž Be able to communicate and discuss appropriately with local health authority.
ž Understand E2B profile including J value and Kenvue Argus J configuration from operational perspective and lead any update activities in cooperation with global stakeholders.ž
Ensure mechanisms in place to collect and receive adverse events from the various source, in partnership with the consumer call center and other functions involved.
ž Ensure a case processing system for OTC drugs, medical devices, cosmetics, and quasi-drugs using a global safety database and accountable for its process.
ž Lead the discussion of case assessment with global medical safety to provide consistent approach.ž
Ensure all local PV quality documents are reviewed and updated to align with global/local requirement.ž
Oversight external vendor for local safety management.ž
Supporting in the responses to safety-related health authority queries in the territory if applicable.
ž Identify issue and problem and have communication with global stakeholders to solve the problems.ž
Recording self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs.
ž Ensure local/global medical or scientific literatures are reviewed to identify any reportable case in accordance with local regulation.
ž Maintain oversight of all required PV regulatory reporting compliance in a timely manner.
ž Ensure all required documents related to PV departmental activities are retained according to regulatory requirements.
ž Ensure PV inspection/audit readiness at the affiliate level at all times.ž
Maintain awareness of local PV legislation and guidelines.ž
Work collaboratively with other functions and regional affiliates to ensure implementation of new company policies and regulatory requirements.

Qualifications
What We Are Looking For

• 5+ years’ of PV related or global safety data base experience in the pharmaceutical industry is strongly preferred

• Native level of Japanese; 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

• Medical, pharmacy or life-sciences degree (or equivalent) is preferred

• Keen in working in a global corporate environment

• People management experience is not must but preferred

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 Drug & Product Safety Operations