職位描述
Principal Accountabilities
Clinical trials: in collaboration with the PV officer and medical reviewers, the CRA and PM, ensure that the information necessary to analyze the PV cases is medically relevant, sufficient and collected within the deadlines. ,
Spontaneous reports and cases from phase 4 and observational trails managed by the subsidiary: Ensure follow-up contact with the reporter and the recovery of appropriate information.
Declare the cases in accordance with local regulations.
Supervise and control the quality of the clinical data, documentation and the narrative of each adverse event requiring immediate notification and supervise the security data in the ICTR clinical trials. Optimize the quality of pharmacovigilance management of cases and medical data by training, advising and giving expertise to ICTR and investigators
Guarantee, in collaboration with the CQAD, the coherence of the local internal procedures that underpin the PV system. Develop, in collaboration with CO QAM, local SOP/OPM in line with corporate policy and the local requirements.
Supervise, manage and develop PV & MR team, ensuring medical excellence in the management of pharmacovigilance.
Within the scope of product risk management, represent the company with local health authorities regarding PV aspects (in collaboration with the pharmaceutical affairs) and in specialized working groups (network of local experts, RDPAC, etc…) industry/specialist groups
Knowledge/ Academic Qualification:
Master degree in medicine is a minimum
Skills:
Excellent written and spoken English
Experience:
Experience in pharmacovigilance is required. Experience with local regulatory environment. Clinical practice experience is very useful.
Competency：
Management skills. Excellent communication skills. Well organized and careful. Able to understand and streamline processes so as to optimize internal procedures.
