Japan Country Safety Officer Associate manager

4日前

Chiyoda Kenvue
Japan Country Safety Officer Associate manager W 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

ž Support the transition to Global Safety database.

ž 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.

ž 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.

ž Lead the discussion of case assessment with global medical safety to provide consistent approarch.

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 Escalate compliance issues in a timely manner to Country safety head to ensure appropriate mitigation is implemented.

ž Advise the local business on the PV impact of local organized data collection programs.

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 possible adverse events.

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

Required Qualifications


• 3~4 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

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