上海招聘

Job Purpose and Key Responsibilities:

l Ensure Pharmacovigilance (PV) compliance according to GSK requirements and local regulation with assistance of line manager or senior staff.

Accountability:

l Collect, translate, report, and follow up post-marketing AEs from all sources to Central team and SFDA in timely manner

l Submit clinical study SAE to SFDA in timely manner

l Distribute Safety Information, e.g. PSRI and MSRI to study team onward to Investigators and ECs

l Submit periodic reports including Periodic Safety Update Report, and oversea Monthly Serious Adverse Drug Reaction Line Listings to SFDA in timely manner

l Literature review to identify reportable AEs.

l Provide drug safety related training to internal and external stakeholder

l Manage PV related documentations appropriately

l Back up to other Safety Associate when required

l Perform other PV related tasks when required

Complexity:

l The holder will need to interact with and manage the expectations of internal stakeholders including but not limited to Clinical Operation, Regulatory Affair, Medical Information, Quality Assurance, Commercials.

l The holder will need to interact with and manage the expectations of external stakeholders including but not limited to Consumer, HCPs, Investigators and China regulator

Basic Requirements:

1. Bachelors degree or above in clinical medicine, pharmacy or a life/biological science

2. Good interpersonal communication skill

3. Good command of both English (written and spoken) and Chinese (written and spoken)

4. Good computer skills including proficiency with Microsoft Word, Explorer and Outlook and familiarity with the internet

5. Good at teamwork

Preferred Requirements:

1. Familiarity with ICH E2 guidelines and relevant local regulations

2. Relevant working experience