Safety Specialist

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 Specialist will work in conjunction with the Associate Director, PV Japan and Pharmacovigilance (PV) 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.

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 local audit/regulatory inspections as applicable
・ 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 5 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

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