• 招聘类型：社招
• 工作性质：全职

职位描述

Job Title: Safety Physician-安全医生

Reports to: Lead of Pharmacovigilance Team

Locations: Shanghai

Job Purpose and Key Responsibilities:

• Performing medical assessment for individual case safety reports according to China safety regulations and Hengrui policy.
• Contributing to the generation of Periodic Safety Update Reports, study reports of Intensive Monitoring Program.
• Communicating with regulatory authorities regarding any safety activities.

Accountabilities:

• Performing medical assessment for individual case safety reports from both clinical trials and post-marketing activities of new marketed products, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events according to China safety regulations and Hengrui policy.
• Reviewing safety associated documents from both clinical trials and post-marketing activities of new marketed products, including labeling, protocols, Investigator Brochure, compensation document and licensing agreements.
• Providing medical input and analysis of Death Investigation Reports, Periodic Safety Update Reports, study reports of Intensive Monitoring Program.
• Serving as the point of contact for communication with regulatory authorities regarding safety related enquiries, safety submissions/reporting such as PSURs, study reports of Intensive Monitoring Program, Risk Minimisation Activities and other safety matters.
• Actively communicating with clinical operations team, medical science team, medical information team and data management team to identify their needs for safety related issues and provide supportive training to internal staff, as appropriate.
• Providing contribution to SAE reconciliation.
• Performing safety reviews and providing medical input for signal management activities and risk management activities for new marketed products.
• Working with line manager to generate and maintain PSMF including but not limited to Standard Operating Procedures, Argus system guilds and source of safety data.
• Working with line manager to prepare and review audit and inspection documents to ensure audit and inspection readiness.
• Working with line manager to proactively and effectively communicate product safety issues and proposed solutions to higher level management team.
• Providing supporting for the mentoring and on-boarding of new PV staffs.

任职条件

Requirements:

• Medical Degree from a medical university. Clinical practice experience in hospital preferred.
• Sufficient pharmaceutical industry experience, with at least four (master degree) to six years (bachelor degree) working experience in pharmacovigilance, clinical research or related fields.
• Good safety database using experience. Argus safety experience preferred.
• Good knowledge of China safety regulations and international regulations and guidance documents from ICH, EU and FDA.

职位要求

• 学历要求：无
• 工作经验：4年
• 外语要求：不需要

公司福利

• 带薪病假 
• 交通补贴 
• 五险一金 
• 年终奖 
• 带薪年休假 
• 补充医疗保险 
• 长期服务奖励 
• 定期体检