Safety Reporting Coordinator
RemoteTaiwan
Job Summary
Receive, prepare, quality check, and submit expedited and periodic safety reports to regulatory authorities, clients, and partners across Taiwan and Singapore. Perform Submission Quality Control (QC) activities and support regulatory submission activities while ensuring all submissions meet applicable timelines and country-specific requirements. Escalate quality, compliance, or timeline issues to management and maintain safety reporting systems and associated documentation accurately. Produce project metrics, identify continuous improvement opportunities, and collaborate with internal departments and external stakeholders to support safety reporting activities. Assist in training new team members and support audit readiness. Supports morning (AM) shift workflow coverage with occasional travel to company or client sites. Fluency in Mandarin Chinese is strongly preferred.
Required Qualifications
- High school diploma or equivalent
- Minimum of two (2) years of experience in Pharmacovigilance, Safety Reporting, or a related healthcare or life sciences environment
- Working knowledge of Pharmacovigilance principles and industry terminology
- Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint
- Strong written and verbal communication skills
- Strong attention to detail and commitment to quality
- Ability to work independently and collaboratively within a team environment
- Ability to identify, prioritize, and resolve issues proactively
- Ability to work effectively under pressure while maintaining quality and compliance standards
- Strong interpersonal skills with the ability to communicate effectively across all levels of the organization
- Demonstrated ability to handle confidential information with discretion
- Ability to identify process improvement opportunities and contribute to operational excellence
- Fluency in Mandarin Chinese (written and verbal)
- Knowledge of Taiwan regulatory submission requirements or experience supporting Taiwan Pharmacovigilance activities
- Experience supporting regulatory safety reporting activities across the APAC region
Desired Qualifications
- Relevant academic or vocational qualification
- Proficiency in additional languages, particularly Korean and/or Japanese
- Flexibility to work extended hours when business needs require
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