Head of Pharmacovigilance APAC
BAYER (SOUTH EAST ASIA) PTE LTD
Healthcare / Pharmaceutical
S$11000 - S$16500
- Functional management of the 11 PV Country Heads (PVCHs) of the APAC Region. Provide strategic, medical safety and process oversight and direction within region. Conduct direct performance and feedback evaluation and development dialogues, independently but in alignment with Country Medical Director
- Manage regional PV resources in APAC region. Accountable for efficient resource utilization within the region. Select (in cooperation with Country Medical Director) new PVCHs according to agreed criteria. Accountable for budget management of the PV cost centres (~4,5mio Euros) in APAC
- Responsible for managing the PV Regional Center APAC
- Accountable to direct PVCHs on safety governance and regional/local implementation of globally defined risk management activities, collect input and feedback from regional / country perspective.
- Responsible to oversee, review and approve relevant safety documents prepared on regional / local level (e.g. local Risk Management Plans) and ensure respective implementation. Review and approval of relevant local safety documents from a global perspective (e.g. local Period Safety Report (PBRERs/PSURs).
- Accountable to ensure local and regional implementation of and compliance with all globally and locally applicable PV processes and systems. Supervise and ensure the creation, update and implementation of local and regional PV QSDs. Through monitoring and analyzing compliance as well as processes itself, PVRH is responsible to drive and accountable to implement respective corrective and preventative actions, as required.
- Accountable to supervise and manage Pharmacovigilance inspections by Health Authorities as well as oversight for PV aspects for internal and external audits in countries of respective region.
- Responsible for a ‘one voice principle’, robust, timely and adequate communication on all relevant ongoing safety topics, including ensuring implementation of relevant safety actions in the respective region. Be an active contributory member of the PV Safety Review Committee, ensuring evaluation of relevant safety topics, deciding on next steps and actions to be taken. Escalation of safety issues to management and governance committees, and represent countries and respective region on concerning safety matters.
- Develop strategic partnerships and network with regional and local key stakeholder (academics, Health Authorities, International/Regional societies, etc.) to monitor and enhance PV regulations and guidelines and to improve harmonization of safety requirements and systems.
- As assigned, execute specific global projects which aim to control, oversee and enhance quality on PV processes and aspects to ensure compliance with internal and esp. external regulations. In particular, the PVRH ensures implementation of any local and/or regional PV legislation from APAC within global PV processes.
Closing on 22 Jan 2021