メディカル・バイオ - 安全性情報（臨床開発・製販後GVP）

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
• 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.
• Ensure that local processes and systems are in place for tracking, processing, submission 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.
• Manage external vendor for local case processing.
• Have communication with global stakeholders to solve the problems.
• 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 all local PV quality documents are reviewed and updated as applicable.
• Escalate compliance issues in a timely manner to Line Manager to ensure appropriate mitigation is implemented.
• 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.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

Required Qualifications
• 2~3 years’ experience working in the pharmaceutical industry is strongly preferred; PV related experience or GxP related 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)
・Experience using global safety database desirable

■職種未経験者：不可