Manager, PV

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, 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 Post-marketing safety studies, and ensure the submission to local health authority. Keep communications with Health Authority on DIM relevant questions.

• Support 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 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.

Job Requirements

-Medical graduates/ 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

-Analytical skill

-Risk assessment

-Strategic Position or Country Specific Strategic Position

-The seniority of this position is based on existing capabilities.