Job Information
Abbott Pharmacovigilance Senior Specialist in Tokyo, Japan
Job Summary:
Lead adverse event (AE) reporting job including maintenance of pharmacovigilance (PV) information technology (IT) system. Ensure compliance with local regulations and Abbott Policy/standard operating procedures (SOPs).
ROLE & RESPONSIBILITIES
- Ensure compliance with local regulations and Abbott Policy/SOPs
a. Collect, review and analyze safety information timely and properly
b. Keep the due date for expedited reports without any late reporting
c. Review and confirm reportability and causality of the adverse drug reaction (ADR) case
d. Prepare safety report for E2B reporting format
e. Handle inspection/audit and reply to inquiries by the authorities/HQs for case level
f. Maintain and upgrades of the PV IT system timely and properly
Prepare or review Periodic Report for unexpected / Non-serious Adverse Drug Reactions and Reports of measures taken overseas, and Research reports such as literature reports.
Support to prepare new package insert (PI) and revise current PI (Revision of Precautions) in timely manner for appropriate use of ANI product in Japan.
Review promotion materials as PV Senior specialist
Support to maintain local SOPs consistency with Abbott global policy/ SOPs
Plan and perform education/training for new staff/junior staff in related field
Control record retention
Provide regular education and trainings for MRs and other relevant personnel
Support handling inspection/audit and reply to inquiries by authorities/corporate in related field
Conduct Affiliate Safety Representative (ASR) or ASR backup activities in compliance with Abbott Nutrition Medical Safety and Surveillance (ANMSS) policy (MSS06-02)
REQUIREMENTS
EDUCATION/TRAINING
Bachelor degree - Required
Science background - Desirable
Minimum Requirements
Ability to manage multi task effectively -Required
PC skill: - Required
English skill: Reading and Writing - Required
Excellent communication and interpersonal skills, both written and spoken -Required
Preferred Requirement
Experience: Working in Pharmacovigilance for drug - 3＋year experience (5＋years CRO experience) - Desirable
Knowledge of Database and system development - Highly desirable
English skill: TOEIC score 600 - Desirable, Speaking – Highly desirable
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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