Safety Manager - Japan

Company Overview
希少疾患を対象とした、画期的なバイオ医薬品を開発・販売している同社。
2023年にはAPAC Regionから独立し、Japan単独Regionとしてさらなる事業拡大フェーズです

Job Description
SUMMARY
The Safety Manager will work in conjunction with the Associate Director, PV Japan and Pharmacovigilance Global 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. The Safety manager is expected to apply experience and professional expertise to conduct all of pharmacovigilance activities.

RESPONSIBILITIES
Participate in the collection and receipt of local adverse events from various sources.
Perform tracking, processing and submission for adverse events and other safety information.
Ensure all required PV regulatory reporting is performed in compliance with the local regulations.
Ensure all pharmacovigilance activities are conducted in accordance with PV Japan’s Standard Operating Procedures (SOPs), Work Instructions (WIs) and local regulatory requirements.
Ensure all required documents related to PV activities are retained according to local regulatory requirements and internal policies.
Support the development and periodic update of the local pharmacovigilance SOPs and WIs
Support the development and continual improvement of pharmacovigilance processes and standard operating procedures for pharmacovigilance in Japan.
Support PV Global with any required local study activities
Perform pharmacovigilance training to internal colleagues as required.
Support local audit/regulatory inspections and work closely with the Associate Director, PV Japan and PV leadership in the implementation of CAPAs following the audits/inspections.
Escalate compliance issues in a timely manner to the Associate Director, PV Japan, PV Global and support appropriate mitigation.
Support the conduct of periodic self-audits of the local PV system.
Perform regular review of local regulatory requirements and best practices and inform Global PV of any changes to local regulations that impact the local or global PV system.
Participate and support JNDA activities as needed.
Perform other activities as directed by Pharmacovigilance management

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

Requirements
EDUCATION
Degree in health sciences (nursing/pharmacy) or life sciences is preferred.

EXPERIENCE
Minimum of 7 years previous pharmacovigilance experience in Japan
Effective communication skills in verbal and written English
Ability to work independently but collaboratively in a matrix organization.
Knowledge of PV regulations
Experience with safety database desirable
Demonstrated attention to detail.
Ability to provide exceptional customer service and professional interactions with a variety of cross-functional colleagues

Additional Job Information
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 (MS WORD, Excel, Power Point) and

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