Country Patient Safety Head
il y a 1 semaine
At Novartis, we are committed to reimagining medicine to improve and extend people's lives. We are seeking a highly skilled and experienced Country Patient Safety Head to join our team in France.
Key Responsibilities:- Provide key leadership skills to the country to meet the strategic vision and regulatory requirements necessary in a large and/or complex country with high regulatory requirements.
- Act as the National/Local Qualified Person or Local Contact Person for Pharmaco-device vigilance in the country and act as the single point of contact with the Local Health Authority on a 24-hour basis concerning Pharmaco-device vigilance matters.
- Ensure oversight of the structure and performance of Novartis PV System at local level.
- Monitor internal compliance for local processing and external compliance (regulatory reporting) according to defined timelines.
- Drive the impact assessment of new local pharmacovigilance-related legislation and provide strategic support to Global PS organization on local PV matters and impact of any changes at country and/or global levels.
- Ensure the local Pharmaco-device vigilance requirements are met.
- Collaborate with Regulatory Affairs (RA) to ensure processes are in place to answer fully and promptly any safety-related requests from Local Health Authorities.
- Manage any local Pharmacovigilance inspection and/or Pharmaco-device vigilance audit and proactively cooperate in the implementation of any corrective/preventative action as determined by auditors/inspectors.
- 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.
- 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.
We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network to stay connected and hear more about our career opportunities.
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