PV Manager

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Job details

Company overview

We are the Japanese subsidiary of a leading U.S. company in the pharmaceutical and healthcare industry, offering a wide range of products. We provide high-quality and high-performance products and services that cover a broad spectrum from diagnostics to treatment, including diagnostic drugs and devices, pharmaceuticals, hospital products, and nutritional supplements. We have earned high praise for our offerings. Naturally, there is also interdepartmental mobility and information sharing, which helps us maintain our overwhelming position as a comprehensive healthcare manufacturer.

Responsibilities

Manage the collection, processing and assessment of safety related information as it relates to the company's Nutrition products in compliance with applicable regulatory requirements and guidelines, as well as division and corporate level policies and procedures; Ensure the pharmacovigilance (PV) system for the company's Nutrition products registered as drugs in Japan is in place and is compliant with regulatory standards; Maintain the PV IT system used for adverse event reporting. The manager is considered a subject matter expert in the area of pharmacovigilance.
Main responsibilities:

• Manage the Japan PV team (through guidance and supervision) in the collection, review, and assessment of adverse event reports/safety related information
• Ensure submission of reportable adverse events to the health authority in accordance with requirements and timeframes outlined in local regulations
• Develop and maintain local standard operating procedures that are aligned with corporate/division level policies and procedures and follow local regulations
• Develop and provide PV training for new/junior team members and local affiliate staff
• Serve as the point of contact for all local PV activities, inquiries and issues, including responding to inquiries from the health authority
• Prepare and submit periodic reports to the health authority in compliance with local regulations
• Conduct internal inspections of the PV system as required by local regulations
• Serve as the PV lead during internal audits and external inspections; prepare and execute CAPAs for any PV related findings
• Participate in the review of promotional materials
• Act as the safety database administrator, including coordinating maintenance and upgrades of the PV IT system
• Manage vendor and process associated with searching of scientific literature for safety related information
• Participate/collaborate with the Medical Safety & Surveillance team on global safety/pharmacovigilance related initiatives and goals
• Functions independently as a decision-maker within specified parameters and decisions could potentially have financial ramifications or impact brand reputation, regulatory compliance, or patient and product safety. 
• Individual is recognized as an internal subject matter expert and resource with responsibilities that require high level critical thinking and analytic abilities.
• Leads cross-functional projects related to the area of expertise with a high level of visibility across the local affiliate site. 
• Responsible for ensuring compliance with local regulatory requirements related to pharmacovigilance for Japan’s drug products.   

Requirements

Minimum requirements:

• Master's degree in related health science area (pharmacy or nutrition desirable) or equivalent skills, education or experience
• 7+ years of experience working in pharmacovigilance for drug or nutritional products
• Sound knowledge of local (Japan) nutritional/pharmacovigilance regulations  
• Experience managing direct reports and leading complex projects related to pharmacovigilance/product safety
• Fluency in spoken/written Japanese and English
• Computer proficient (Windows, Word, Excel); experience working in adverse event/safety databases
• Excellent communication and interpersonal skills, both written and spoken
• Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects
• Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity

Salary

10 - 13 million yen

Location

Tokyo