Registered Senior Pharmacist

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.)