Position Summary

Performs drug safety medical review and signal evaluation for reports received from various sources to provide high quality drug safety service delivery to clients. Distributes reports and data to both internal and external parties following applicable regulations, SOPs and internal guidelines. Provide operational support across all safety service lines as appropriate.

Key Responsibilities

Conduct Safety Medical Review

• Perform single case medical assessment, including the determination of seriousness, expectedness / listedness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, and case processing / coding conventions.
• Identify and evaluate safety signals based on individual cases and cumulative data assessment. Communicate these findings proactively and effectively to the key stakeholders.
• Provide medical advice and insights to department colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports.
• Develop and maintain comprehensive and current knowledge for the assigned project and product portfolio.

• Develop and maintain a comprehensive working knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures, and case processing / coding conventions.

• Support medical and safety monitoring on clinical development projects as needed.
• Develop therapeutic area knowledge and safety medical review process expertise

Support Project Management and Contribution to Team Result

• Support the achievement of the team case processing performance timelines.
• Liaise with clients and relevant parties, e.g. project management, clinical, data management, investigators, medical monitors, and site coordinators to address project issues and identify issue resolution.
• Assist with administrative support e.g. project start-up tasks, creation and maintenance of project files, systems access requests, coordinating team/department/customer/project oversight group meetings.

• Collaborate cross Drug Safety & Pharmacovigilance sub-function lines for seamless cooperation on projects and service delivery.

Comply with Regulatory and Quality Requirements

• Ensure consistency and quality of the medical review process.
• Ensure compliance to all necessary dMed standard operating procedures (SOPs) and customer SOPs, and all required trainings are executed in a timely manner and documented.
• Take responsibility for audit/inspection readiness for pharmacovigilance medical review activities; support audit and regulatory authority inspections when needed.
• Learn regulatory requirements and policy changes to apply to the work for compliance.

Education and Key Competency Requirements

Professional Experience and Education Requirements

• Medical Degree from an accredited institution, PhD preferred.
• Minimum of two years of experience as a licensed physician in clinical practice.
• Minimum of two years of relevant experience in pharmacovigilance or clinical research in biopharmaceutical industry.
• Working knowledge of international regulations and guidance documents governing safety evaluation and reporting. General knowledge about clinical development process.

Key Competency Requirements

• Knowledge of pharmacovigilance processes or in particular pharmacovigilance function line; willingness and aptitude to learn new skills across pharmacovigilance service lines.
• Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs).
• Excellent attention to detail and accuracy and maintain consistent high-quality standards.
• Ability to follow instructions / guidelines, plan own work, work independently with can-do attitude.
• Ability to be flexible and receptive to changing process demands.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Fluency in oral and written English, with solid capability in writing medical and scientific materials or content.

上班地址：东湖新技术开发区高新大道666号光谷生物城生物创新园B1栋4楼445