Job Purpose and Key Responsibilities:

? Managing individual case from both clinical trials and post marketing activities according to China safety regulations and Hengrui policy.

? Contributing to the generation of Periodic Safety Update Reports, study reports of Intensive Monitoring Program.

? Mentoring and or training team members.

Accountabilities:

? Performing case information verification, case assessment including events selection, case classifications (validity, seriousness, expectedness/listedness/labelledness) and reportability and quality control for individual case safety reports according to China safety regulations and Hengrui policy.

? Submission of SAEs and ADRs to regulatory authorities according to China safety regulations and Hengrui policy.

? Contributing to the generation and submission of Periodic Safety Update Reports, study reports of Intensive Monitoring Program.

? Providing mentoring and on-boarding support to new PV staff.

? Serving as the point of contact in communication with regulatory authorities for safety related enquiries, safety submissions/reporting such as PSURs and study reports from Intensive Monitoring Program, Risk Minimisation Activities and other safety matters.

? Cooperating 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.

? Making contribution to SAE reconciliation.

? Reviewing and providing SAE aggregate lists to clinical operations team as appropriate.

? 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 head of higher level management team.

Requirements:

? Health Care Professional or equivalent experience required. Medical degree from a medical university 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.

? Good communication skills.

上班地址：浦东新区张江高科技开发园区恒瑞大楼（海科路近哥白尼路）