Country Patient Safety Head
il y a 1 semaine
We are seeking a highly experienced and skilled Country Patient Safety Head to join our team at Novartis. As a key member of our local leadership team, you will be responsible for establishing and driving Patient Safety (PS) strategy and operational excellence at country level.
Key Responsibilities:- Collaborate with the global patient safety and local leadership to establish and drive PS strategy and operational excellence at country level.
- Ensure the oversight of the quality management system for the PV system at local level, in collaboration with the Quality Assurance (QA) function.
- Head the local PS department and ensure the country is meeting its regulatory obligations to the local health authority.
- Act as the National/Local Qualified Person or Local Contact Person for Pharmaco-device vigilance in the country (ies) and act as the single point of contact with the Local Health Authority on a 24-hour basis concerning Pharmaco-device vigilance matters.
- Ensure the country oversight of Patient Oriented Programs (POPs) held at local level, in line with Novartis procedures and applicable regulations/standards/guidelines.
- Act as the operational manager of the POP Champion Lead/Manager/Specialist for the country, as applicable.
- Quality (i.e. accurate, complete and timely) of local PV deliverables.
- High PV compliance at country level.
- Country PS team adequately resourced and with high competencies.
- Country PS team audit/inspection ready.
- Successful audit/inspection outcomes (no critical findings under PS responsibility).
- Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience.
- Fluent in both written and spoken English and French.
- Minimum 7 years' experience in drug-safety or pharmacovigilance (preferred) and/or experience in pharmaceutical industry.
- Minimum 2-3 years of demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry.
- Extensive knowledge of regional and local requirements relating to PV. Ability to solve complex regulatory issues and requirements.
- Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains. Ability to effectively communicate with different stakeholders.
- Experience in PV audits and inspections.
- Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
- Experienced leader in a matrix organization, including ability to influence and provide guidance and direction to team members.
- Demonstrated ability for innovative and big picture thinking.
- Strong planning, negotiation, organizational and interpersonal skills.
- Computer/IT systems literacy.
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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