Pharmacovigilance Specialist (Submissions specialist) Taiwan

AI overview

Manage submission workflows and ensure regulatory compliance for safety reporting, handling submissions and documentation for pharmaceutical projects in Taiwan.

The Submission Specialist is responsible for the timely and accurate management of regulatory submission activities at the project level. The role includes reviewing submission data packages for completeness and regulatory compliance, supporting preparation activities, and ensuring adherence to applicable safety reporting requirements.

The Specialist manages submission workflows, coordinates timely submissions, tracks submission status, collects acknowledgements, and ensures proper documentation and archiving in line with project and country-specific regulations. Regular communication with clients regarding submission status is also required.

Responsibilities:

Submission data package review for completeness, accuracy and regulatory reportability

Assisting the client in and/ or submission data package preparation
Maintaining and/ or applying of safety reporting regulatory intelligence
Submission process workflow management for expeditive (foreign and local) and periodic reports (PSUR, DSUR).
Performing/ coordinating timely submission of submission data package
Acknowledgement of receipt/ proof of submission collection
Tracking of safety submissions
Documentation filing and archiving according to project and country specific requirements
Notification on submission status to the client/ responsible party
Communication with TFDA as applicable
Performing trainings on time

Requirements

Bachelor’s degree in Life Sciences field
Minimum 1 year of experience in pharmacovigilance or safety case processing within the pharmaceutical or CRO industry in Taiwan
Fluency in Mandarin Chinese (Simplified Chinese) and English languages (Mandatory)
Experience with case submissions to local Health authorities (Mandatory)
Hands-on experience with Argus Safety, Veeva Vault or similar safety databases is preferred
Strong proficiency in MS Office applications
Ability to work independently while managing multiple cases and deadlines
Candidates needs to be based in Taiwan