摘要
About the Role
About this role:
Ensuring robust control and oversight of the global pharmacovigilance system and spearhead the production of the Pharmacovigilance System Masterfile (PSMF) in line with Good PV practices. Step up to the challenge and deputize for the EU-QPPV and Global Head of the QPPV Office when needed, making a significant impact in the world of pharmacovigilance.
Key Responsibilities include (but are not limited to):
- Develop and lead strategic direction for QPPV office in form of allocation of resources, setting of priorities and development of strategies to deal with global Health Authorities in alignment with EU QPPV and Global Head QPPV Office
- Drive simplification and building of sustainable end-to-end processes to promote, maintain and improve PV system performance, quality and compliance
- To oversee the maintenance of the PSMF for the pharmacovigilance system of Novartis in EU/EEA and non-EU/EEA countries with a QPPV requirement
- Manage senior stakeholders across company to ensure delivery of required oversight to QPPV office and ensure input to global PV system across organization
- Act as deputy in absence of EU-QPPV and Global Head of QPPV Office for delegated activities
Required Background
- MD, PharmD or PhD in Life Sciences
- Broad expertise in all key aspects of PV, preferably QPPV experience, eg Deputy QPPV
- Current experience of working in an EU country with EMA or a local competent authority
- Fluent in English (both oral and written),
- Fluent Spanish would be an advantage
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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