Pharmacovigilance Senior Specialist

Abbott

Abbott

Tokyo, Japan
Posted on Thursday, July 11, 2024

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

1. 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

2. 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.

3. 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.

4. Review promotion materials as PV Senior specialist

5. Support to maintain local SOPs consistency with Abbott global policy/ SOPs

6. Plan and perform education/training for new staff/junior staff in related field

7. Control record retention

8. Provide regular education and trainings for MRs and other relevant personnel

9. Support handling inspection/audit and reply to inquiries by authorities/corporate in related field

10. 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