A Senior Adviser is mainly deployed on –

• (a)setting up the registration system for pharmaceutical products under the primary evaluation approach;
• (b)providing professional advice on the implementation of primary evaluation and assisting in the capacity building of officers in Drug Office;
• (c)evaluating applications of registration of pharmaceutical products and preparation of assessment reports;
• (d)advising on clinical trials involving innovative pharmaceutical products and evaluating applications for their clinical trial certificates;
• (e)developing standards and guidelines relating to registration of innovative medical products; and
• (f)performing any other duties as assigned by seniors.

(Remark: May be required to perform on-call duties or work outside normal office hours.)

Candidates should –

• (a)have a Doctoral Degree in related subjects

OR

• (b)have a Master's Degree in related subjects

AND

• (c)have proficiency in written Chinese and English, and good command of spoken Cantonese, Putonghua or English; and
• (d)preferably have worked in drug regulatory authorities outside Hong Kong with experience in the following area(s):
  • (i)evaluation of applications for authorisation or approval of clinical trials of pharmaceutical products or medicines;
  • (ii)evaluation of applications for registration or marketing authorisation of pharmaceutical products or medicines;
  • (iii)development of regulatory guidelines and procedures for pharmaceutical products or medicines relevant to the evaluation of the said applications;
  • (iv)participation in any Working Group of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; or
  • (v)analysis of adverse events and/or safety data from all sources across the lifecycle of pharmaceutical products or medicines and formulating policies relating to safety surveillance, risk evaluation and risk mitigation strategies.