Japan Safety Lead - Anseki

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The Safety Management Officer will oversee all safety management and pharmacovigilance (PV) activities in Japan.
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This role involves ensuring compliance with local regulations, managing risk, and maintaining high standards of safety for all products.
Client Details
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A global biotechnology firm specializing in precision therapies for cancer, with a strong presence in multiple countries.
Description
* Oversee and manage safety documentation and actions for all products.
* Ensure compliance with local PV regulations and legal requirements.
* Maintain and continuously improve the PV system, fulfilling responsibilities as a Marketing Authorization Holder (MAH).
* Develop and manage Risk Management Plans, PMS plans, Aggregate Reports, and other key PV documents.
* Oversee safety activities in local clinical studies and post-marketing PV regulatory commitments.
* Ensure appropriate management of external vendors.
* Provide leadership within global and local teams, ensuring clear communication and coordination.
Profile
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Bachelor's degree or higher in a life science-related field or a healthcare professional background (e.g., nurse, pharmacist, or physician) preferred.
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Extensive experience in pharmacovigilance within the pharmaceutical industry.
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In-depth knowledge of current PV regulations and procedures.
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Experience in developing SOPs, RMPs, and other PV documents.
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Strong vendor management and oversight skills.
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Business-level proficiency in English (writing, reading, and speaking).
* Fluenc in Japanese
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Proven experience in organizational leadership.
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Knowledge and experience in managing device safety reports is desirable.
Competencies:
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Strong analytical and problem-solving skills.
* Excellent organizational and multitasking abilities.
* Effective communication and interpersonal skills.
* High attention to detail and commitment to quality.
Job Offer
* Contribute to the safe development of drugs for patients with unmet medical needs in oncology areas
* Work with global colleagues in APAC and US
Page Group Japan is acting as an Employment Agency in relation to this vacancy.