Position Summary

Manages drug safety medical review, signal evaluation and riskmanagement, and distributes reports and data to both internal andexternal parties following applicable regulations, SOPs and internalguidelines. Provide operational support across all safety service linesas appropriate.

Key Responsibilities

Conduct Safety Medical Review

1. Perform single case medical assessment, including the determinationof seriousness, expectedness / listedness, and causality of adverseevents in compliance with current regulations, internal and externalguidance documents, Standard Operating Procedures, and case processing /coding conventions.

2. Develop aggregate safety reports required by regulatory agencies,when authorized to perform this function on behalf of a client.

3. Identify and evaluate safety signals based on individual cases andcumulative data assessment. Communicate these findings proactively andeffectively to the key stakeholders.

4. Develop safety risk management strategy and plan through theidentification, assessment, communication, and minimization of risk forthe products per client or project needs.

5. Provide medical advice and insights to department colleagues toimprove the quality, consistency, accuracy, and clinical relevance ofsafety reports.

6. Develop and maintain comprehensive and current knowledge for theassigned project and product portfolio.

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

8. Support medical and safety monitoring on clinical developmentprojects as needed.

9. Develop therapeutic area knowledge and safety medical review processexpertise.

Support Project Management and Contribution to Team Result

1. Support the achievement of the team case processing performancetimelines.

2. Liaise with clients and relevant parties, e.g. project management,clinical, data management, investigators, medical monitors, and sitecoordinators to address project issues and identify issue resolution.

3. 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.

4. Collaborate cross Drug Safety & Pharmacovigilance sub-functionlines for seamless cooperation on projects and service delivery.

Comply with Regulatory and Quality Requirements

1. Ensure consistency and quality of the medical review process.

2. Ensure compliance to all necessary dMed standard operating procedures(SOPs) and customer SOPs, and all required trainings are executed in atimely manner and documented.

3. Take responsibility for audit/inspection readiness forpharmacovigilance medical review activities; support audit andregulatory authority inspections when needed.

4. Learn regulatory requirements and policy changes to apply to the workfor compliance.

Professional Experience and Education Requirements

1. Medical Degree from an accredited institution.

2. Experience as a licensed physician in clinical practice is a plus.

3. Minimum of two years of relevant experience in pharmacovigilance orclinical research.

4. Working knowledge of international regulations and guidance documentsgoverning safety evaluation and reporting. General knowledge aboutclinical development process.

Key Competency Requirements

1. Knowledge of pharmacovigilance processes or in particularpharmacovigilance function line; willingness and aptitude to learn newskills across pharmacovigilance service lines.

2. Good understanding of applicable global, regional, local clinicalresearch regulatory requirements; i.e. Good Clinical Practice (GCP) andInternational Conference of Harmonization (ICH) guidelines, StandardOperating procedures (SOPs).

3. Excellent attention to detail and accuracy and maintain consistenthigh-quality standards.

4. Ability to follow instructions / guidelines, plan own work, workindependently with can-do attitude.

5. Ability to be flexible and receptive to changing process demands.

6. Ability to establish and maintain effective working relationshipswith coworkers, managers and clients.

7. Fluency in oral and written English, with solid capability in writingmedical and scientific materials or content.

上班地址：上海市浦东新区祥科路298号佑越国际，3楼301-305