Key Accountabilities/Responsibilities:

NSC role of China Vaccines
Creation and maintenance of the Operating Company SOP for the receipt, investigation and reporting of adverse events, incidents, near incident and pregnancies associated with GSK developmental compounds and marketed products – referred to as the local SOP for pharmacovigilance, materiovigilance and human safety related activities

Day to day management of AE, incident, near incident and pregnancy reports

Literature and other mass communication media reports

Reviewing all local clinical study proposals/protocols to ensure adequate safety requirements are met

Ensuring that, as far as possible, translations into English are completed within the agreed time frames for reporting of locally identified cases to a Central Safety Department

Ensuring that there is an established process for liaison with the relevant departments dealing with product complaints and medical enquiries and regular review of local product complaint log, to ensure that AE, incident and near-incident or pregnancy information reported in association with a product complaint or medical enquiry is notified to the NSC

Forwarding periodic safety update reports (PSURs) to the local regulatory authority with a covering letter outlining any significant differences between the core safety information and the local data sheet

Providing training to Operating Company staff including field-based representatives and clinical development staff on pharmacovigilance and materiovigilance

• Perform medical review of promotional materials for GSK China product portfolio, ensuring high quality from scientific and ethical point of view
  
• Provide cross functional medical support, including make presentations in different meeting/conference
  
• Develop high-quality relationships with KOLs in field of vaccines of GSK interest.
  
• Perform medical review of packaging materials including package insert leaflets.
  
• In association with Medical Affairs Director, review investigator initiated studies requests
  
• Participate in Brand Team meetings and make the inputs from Medical point of view
  
• Brief sales and marketing staff on updating of relevant SOP’s.
  

Qualifications:

• Medically qualified
• Clinical experience required
  
• Industry experience preferred
  
• Experience in field of vaccine preferred but not essential