A Registered Senior Pharmacist is mainly deployed on -

• (a)To perform preparatory work for phased implementation of primary drug evaluation and restructuring of overall drug evaluation framework / infrastructure;
• (b)To prepare for and to oversee the implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) Guidelines;
• (c)To modify the existing local pharmacovigilance (PV) framework to go on a par with international standard;
• (d)To study and compare overseas drug regulatory regimes / organisational structure / legal framework, with that of Hong Kong, and formulate a governance and command structure that suits the future need of Hong Kong;
• (e)To review and propose appropriate amendments to current legislation on drugs;
• (f)To oversee the preparation and implementation of guidelines and standards relating to the regulation of pharmaceutical products, such as Good Review Practice, Good Clinical Practice, Good Pharmacovigilance Practice, etc.;
• (g)To be responsible for making recommendations to the Pharmacy and Poisons Board of Hong Kong in relation to the guidelines and standards in (e);
• (h)To be responsible for engaging and communicating with local stakeholders on the revised guidelines and standards in
• (e)and plan for their implementation;
  • (i)To coordinate the collaborations with the Chinese Mainland and international institutes and organizations on matters relating to the revised guidelines and standards in (e);
• (j)To lead a team of professional staff to (i). process applications of new drug registration, renewal registration and change of registered particulars under both primary and secondary evaluation approach; (ii). conduct local and overseas adverse drug reaction monitoring, assessment and signal detection; (iii). evaluate applications for Clinical Trial/Medicinal Test Certificates; or (iv). conduct inspections on Good Clinical Practice, etc.; and
• (k)To perform 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)be registered with the Pharmacy and Poisons Board of Hong Kong established under the Pharmacy and Poisons Ordinance, Chapter 138;
• (b)hold a valid Practising Certificate issued by the Pharmacy and Poisons Board of Hong Kong;
• (c)have at least fifteen years’ relevant post-registration experience (Notes 1-2);
• (d)have good project management skills and communication skills; and
• (e)proficiency in written Chinese and English, and good command of spoken Cantonese, Putonghua and English.

Candidates who have previous working experience in drug regulatory authority or pharmaceutical industry on drug regulatory affairs, health informatics, pharmacovigilance, clinical trials, and/or candidates who have worked in drug regulatory authorities outside Hong Kong will have an advantage.