Safety Reporting Coordinator

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• Receive, prepare, conduct quality checks, and submit expedited and periodic safety reports to relevant regulatory authorities, clients, and partners.

• Assist with regulatory submission processes for Taiwan.

• Execute regulatory submissions for Singapore.

• Conduct Submission Quality Control (QC) activities across workflows in Taiwan and Singapore.

• Ensure that all submissions are accurately completed within the specified regulatory timelines and country-specific requirements.

• Report any quality, compliance, or timeline concerns to the Team Lead or Manager as needed.

• Maintain safety reporting systems and related documentation in a prompt and precise manner.

• Generate project metrics and aid in reporting activities while pinpointing opportunities for continuous improvement.

• Collaborate with internal teams, clients, and external partners to facilitate safety reporting and project execution.

• Exhibit a robust understanding of Standard Operating Procedures (SOPs), Guidance Documents (GDs), and project-specific documentation.

• Proactively resolve operational issues with minimal supervision.

• Provide operational updates and work status to management as necessary.

• Engage in continuous improvement initiatives and share ideas to enhance operational efficiency.

• Assist in training and mentoring new team members in Pharmacovigilance and Safety Reporting, as necessary.

• Support audit and inspection readiness activities.

• Perform tasks in alignment with project Key Performance Indicators (KPIs).

⛳️ Requirements

• High school diploma or equivalent is required.

• Relevant academic or vocational qualifications are preferred.

• A minimum of two (2) years of experience in Pharmacovigilance, Safety Reporting, or a related healthcare or life sciences field.

• An equivalent combination of education, training, and relevant experience may be considered.

• Familiarity with Pharmacovigilance principles and industry terminology.

• Proficient in Microsoft Office applications, including Word, Excel, and PowerPoint.

• Strong written and verbal communication skills.

• Exceptional organizational and time management abilities with the capability to handle multiple priorities and deadlines.

• Keen attention to detail and a commitment to quality.

• Ability to work both independently and collaboratively within a team.

• Capacity to identify, prioritize, and proactively resolve issues.

• Ability to perform effectively under pressure while upholding quality and compliance standards.

• Strong interpersonal skills with effective communication across all organizational levels.

• Proven ability to manage confidential information discreetly.

• Capability to identify process improvement opportunities and contribute to operational excellence.

• Proficiency in Mandarin Chinese (written and verbal) is strongly preferred to assist in Taiwan regulatory submission activities.

• Knowledge of Taiwan regulatory submission requirements or experience in Taiwan Pharmacovigilance activities is desirable.

• Proficiency in additional languages, particularly Korean and/or Japanese, is considered an asset but is not mandatory.

• Experience in supporting regulatory safety reporting activities throughout the APAC region is advantageous.

🏝️ Benefits

• Office-based work environment with most tasks performed using computer systems.

• Supports morning (AM) shift workflow coverage.

• Occasional travel to company or client locations may be necessary.

• Flexibility to work extended hours as business needs arise.