Job Information
Abbott <ANI事業部> Pharmacovigilance Manager in Tokyo, Japan
Primary Job Function:
Manage the collection, processing and assessment of safety related information as it relates to Abbott 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 Abbott 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.
Core Job 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
Supervisory/Management Responsibilities:
Direct Reports: 2 (1 full time Abbott employee, 1 contract employee)
Indirect Reports: 0
Position Accountability/Scope:
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.
Minimum Education:
Master's degree in related health science area (pharmacy or nutrition desirable) or equivalent skills, education or experience
Minimum Experience/Training Required:
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
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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