Being a safety manager to be responsible for TA related PV activities. It includes ensuring compliance with all local regulations and GSK global PV requirement, and includes but not limited to :
Prepare and Submit PSURs and other periodic safety updates to Regulatory Authorities, Investigators and Ethics Committees as required.
Coordinate local Product Risk Management Plan in partner with local TMT and central SERM team.
Represent safety expertise in TMT for both development products and post-marketing products. Provide safety input on cross-functional team set up to address urgent and important safety issue.
Review and provide technical input for clinical study protocol, clinical study report and local prescribing information.
Ensure promptly notify central SERM head or QPPV of any potential local PASS or Target Safety Study.
outinely monitor and escalate local safety issue potentially related to a product defect, manufacturing issue, or local medical practice.
Training of all operating company staff in AE reporting.
Communicate with local HA if there is any queries received.
To provide the CSD with the monthly summary of compliance indicators for Pharmacovigilance reports processed locally and other data required.
Being a role model of complying company policy and code of conduct; Ensure direct reports complying company policy and code of conduct, and ensure internal cost controlled within annual budget.
Assist NSC on resource and budget planning and implementation.
Basic Qualifications :
Minimum three years’ experience in Health Industry including 5 years in the relevant function, e.g. Pharmcovigilance, Clinical Operation, Quality Assurance, Medical Information and etc.
Bachelor degree or above in clinical medicine, pharmacy or a life / biological science
Good interpersonal communication skill
Good command of both English (written and spoken) and Chinese (written and spoken)
Good computer skills including proficiency with Microsoft Word, Explorer and Outlook and familiarity with the internet
Good at teamwork
Experience from MNC is preferred