Work Schedule

Environmental Conditions

Job Description

Safety Reporting Coordinator (SRC)

Position Summary

The Safety Reporting Coordinator (SRC) provides administrative safety reporting support to the Pharmacovigilance department and is responsible for the preparation, quality review, and submission of expedited and periodic safety reports. This role ensures submissions are completed accurately and in compliance with applicable regulatory requirements, client expectations, and country-specific legislation.

This position supports regulatory safety reporting activities across the Asia-Pacific (APAC) region, with a primary focus on Taiwan and Singapore. The successful candidate will contribute to regulatory submissions, Submission Quality Control (QC), process improvements, operational reporting, and cross-functional collaboration to ensure the timely delivery of high-quality safety reporting services.

Key Responsibilities

• Receive, prepare, quality check, and submit expedited and periodic safety reports to applicable regulatory authorities, clients, and partners.
• Support regulatory submission activities for Taiwan
• Perform Singapore regulatory submissions
• Perform Submission Quality Control (QC) activities across Taiwan and Singapore workflows.
• Ensure all submissions are completed accurately and within applicable regulatory timelines and country-specific requirements.
• Escalate quality, compliance, or timeline issues to the Team Lead or Manager, as appropriate.
• Maintain safety reporting systems and associated documentation in a timely and accurate manner.
• Produce project metrics and support reporting activities while identifying opportunities for continuous improvement.
• Collaborate with internal departments, clients, and external stakeholders to support safety reporting activities and project implementation.
• Demonstrate a strong understanding of Standard Operating Procedures (SOPs), Guidance Documents (GDs), and project-specific documentation.
• Proactively troubleshoot operational issues with minimal supervision.
• Provide operational updates and work status to management as required.
• Participate in continuous improvement initiatives and contribute ideas to enhance operational efficiency.
• Assist in training and mentoring new Pharmacovigilance and Safety Reporting team members, as required.
• Support audit and inspection readiness activities.
• Perform work in accordance with project Key Performance Indicators (KPIs).

Qualifications

Education & Experience

• High school diploma or equivalent required.
• Relevant academic or vocational qualification preferred.
• Minimum of two (2) years of experience in Pharmacovigilance, Safety Reporting, or a related healthcare or life sciences environment.
• An equivalent combination of education, training, and directly related experience may be considered.

Knowledge, Skills & Abilities

• Working knowledge of Pharmacovigilance principles and industry terminology.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Strong written and verbal communication skills.
• Excellent organizational and time management skills with the ability to manage multiple priorities and deadlines.
• 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) is strongly preferred to support Taiwan regulatory submission activities.
• Knowledge of Taiwan regulatory submission requirements or experience supporting Taiwan Pharmacovigilance activities is desirable.
• Proficiency in additional languages, particularly Korean and/or Japanese, is considered an asset but is not required.
• Experience supporting regulatory safety reporting activities across the APAC region is advantageous.

Working Conditions

• Office-based work environment with the majority of work performed using computer systems.
• Supports morning (AM) shift workflow coverage.
• Occasional travel to company or client sites may be required.
• Flexibility to work extended hours when business needs require.

Management Responsibility

This position has no direct people management responsibilities.