Manager, PV Physician
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, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job 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, Clinical Trial Protocol (CTP), Clinical Trial Report (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 Risk Management Plan (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 Post-marketing safety studies, and ensure the submission to local health authority. Keep communications with Health Authority on Drug Intensive Monitoring (DIM) relevant questions.
• Support Local Patient Safety Lead(LPSL) on maintenance of local PV system and Contributes to the PV Quality system:
- Support LPSL 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 LPSL to ensure local PV inspection readiness and participation in PV audits and local PV inspections
- Cooperating with Global Pharmacovigilance(GPV) compliance in identification of PV and PV relevant non-compliances (NCS) occurring during routine business and timely Corrective Action Preventive Action(CAPA) development and implementation as assigned for Non-Clinical Safety, observations from PV audits and inspections.
Job Requirements
- Master's degree or above. Major/Focus Clinical Medicine
- Excellent academic knowledge and medical judgment
- Strong communication and influencing skills
- Team work and collaboration
- Leadership in driving cross functional projects
- Good analytical skill
- Good capability in risk assessment