JOB DESCRIPTION:

• 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.  

• 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. 

• Master's degree in related health science area (pharmacy or nutrition desirable) or equivalent skills, education or experience 

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Medical & Scientific Affairs

     

DIVISION:

ANRD Nutrition Research & Development

        

LOCATION:

Japan > Tokyo : Mita South Tower

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable