Senior Drug Safety Manager
GSK
HuangPu District, Shanghai, China (Mainland),
1天前

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.
  • Why you?

    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
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