仕事の内容
Our Client: Our client is one of the top leading pharmaceutical companies, headquartered in Japan. They are currently looking for a PV/ RA/ QM Executive to join their Singapore Office. The Responsibilities: • Maintains current knowledge, ensures compliance, and communicates with the relevant global, regional and local functions of the local regulatory requirements. • Review, process and forwards safety events (pre-marketing and post-marketing) and/or other medically related information to Global PV and submits such safety events to the local health authority according to relevant global/local SOPs and local requirements. • Perform review of abstracts and full articles to identify safety information from literature source. • Support creation, management, and oversight of local RMP and all RMP-related PV activities. • Liaise with investigational site and reporter as necessary regarding safety issues. • Develop local PV training material and conduct PV training as per relevant SOPs. • Prepare, review, update and maintain PV clauses in all relevant agreements from PV perspective. • Manages and conducts oversight of Aggregate Report submission to the applicable local health authorities. • Perform reconciliation of safety information with relevant internal and external functions. • Develop and maintain PV Business Continuity Plan in accordance with global SOPs. • Preparing registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in the local market
応募条件
The Requirements: • Degree in Pharmacy with 1-3 years of experience in PV and/or RA experience in Singapore pharmaceutical industry • Singapore licensed Pharmacist required • Strong organizational and process management skills. • Teamwork and collaboration with cross functional teams RGF Privacy Policy – https://www.singapore.rgf-professional.com/privacy-policy Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep. JO Reference: 114306