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About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.
Responsibilities:
Review and provide scientific guidance from drug safety and risk management standpoint on documents submitted to Health Authority, including but not limited to individual Case Safety Report, Local label, CTP, CTR etc.
-Draft out safety reports to Health Authority per regulation: Safety summary for license renewal, regular safety reports, and fatal/cluster case investigation reports.
-Generate local RMP, ensure the implementation and evaluation according to local regulatory requirements. Make sure RMP training is given to all relevant stakeholders.
-Review local safety data, generate reports per requirements and keep necessary communication with relevant stakeholders.
-Deliver PV knowledge or Product safety training to internal and external customers.
-Lead the strategy discussion for Drug Intensive Monitoring (DIM), and ensure the submission to local health authority. -Keep communications with Health Authority on DIM relevant questions.
-Support LPVM on maintenance of local PV system and Contributes to the PV Quality system:
-Support LPVM to ensure that the PV Local Working Instruction and the local PV system repository correctly describe the local PV system and reflect global PV relevant processes as well as specific local requirements.
-Support LPVM to ensure local PV inspection readiness and participation in PV audits and local PV inspections
-Cooperate with GPV compliance in identification of PV and PV relevant non-compliances (NCs) occurring during routine business and timely CAPA development and implementation as assigned for NCs, observations from PV audits and inspections.
Requirements:
-Medical graduates / Master’s degree or above, with a major/focus in Clinical Medicine
-Excellent academic knowledge and medical judgment
-Strong communication and influencing skills
-Good teamwork and collaboration
-Leadership in driving cross functional projects
-Analytical skill
-Risk assessment
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.