Director Patient Safety Apma Hub

1886 We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in Generics and Biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
- The Director Patient Safety HUB is responsible for operational oversight and governance of Pharmacovigilance activities for all Sandoz group companies including external service providers (3rd party vendors) working on behalf of Sandoz in a complex region that has large countries which have commercial and regulatory impact.
- The role will need to have strong collaboration and negotiation skills with high-level leaders at the local/global level as well as external stakeholders and 3rd party vendors. Ability to influence and partner with local and global stakeholders and 3rd party vendors to meet all Sandoz objectives and standards.
- This role will also have to have a forward-facing role with the local Health Authorities in the respective region. In alignment with Global Head Countries and Regions, develop and execute strategy established at the global level for Pharmacovigilance Safety Operations in the region. Prepare and establish respective strategic metrics in the region based on globally defined metrics.**Your Responsibilities**:
Your responsibilities include, but not limited to:
- Leadership: In collaboration with the Global Head Countries and Regions (GHC&R) and 3rd party vendor, lead the region to meet the strategic vision and regulatory requirements in a complex region with large countries in high regulatory demand and high impact to the organization. Lead and manage Regional HUB, Countries/Clusters as direct and indirect manager. Act as GHC&R deputy (as applicable). Supervise the regional activities via close monitoring and interaction with 3rd party vendor, ensuring alignment and strategies, priorities, and initiatives at the local and regional level.
- Director Patient Safety HUB Safety Oversight: In conjunction and aligned with global strategies, utilize robust PV operational knowledge and strong PV management expertise to support Countries and Regions (C&R), 3rd party vendor in defining and driving priorities, strategies, and objectives to assure oversight in a complex region with high regulatory demand. Support the GHC&R in providing input, expertise and leadership as required to support the overall patient safety organization and the regional organization. Play key role in internal and external stakeholder/3rd party vendor management in the region and globally.
- Management of Safety Information: Partner with GHC&R to ensure oversight of the 3rd party vendor and the structure and performance of Sandoz PV System at regional and country level, to promote, maintain and improve compliance aspects.
- Monitoring internal and external compliance of Safety Reports: Monitor internal and external compliance for local processing and regulatory reporting according to defined timelines. Ensure that delayed safety cases or aggregate reports are accurately collected by 3rd party vendor, investigated and root causes addressed through any corresponding corrective/preventative action. Ensure that all identified delays trends are immediately reported to GHC&R and EU QPPV.
- Oversight of 3rd party vendors working on behalf of Sandoz: Monitor and assess the performance and productivity of 3rd party vendors in line with the applicable regulations, agreements, and standard operational/ working procedures in place. In collaboration with QA, GHC&R and Vendor Management functions, ensure corrective and/or preventive actions are implemented in case contractual commitments are not met, as applicable.
- Regulatory Intelligence: In collaboration with 3rd party vendor support the GHC&R to drive the impact assessment of new local pharmacovigilance-related legislation and provide operational expertise and strategic support PV matters and impact of any changes at country/cluster/region and/or global levels.
- Compliance with Local/Region Legislation: In collaboration with 3rd party vendor and in conjunction with the GHC&R, coordinate and execute the implementation of new/modified local and/or regional Pharmaco-Device vigilance regulatory legislation and inspection readiness to ensure local and global compliance objectives are met to a high standard. Where appropriate, the Director Patient Safety HUB Safety, will provide leadership and expertise to shape evolving Pharmaco-Device strategies of implementation to adapt to new regulations.
- Health Authority Requests: In collaboration with 3rd party vendor, Regulatory Affairs (RA) and other functions ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities in the region; ensure alignment with defined process and QPPV office in all safety-related responses, as applicable.
- Audits, Self-assessments, and Inspections: In collaboration with the QA applicable groups, manage any local PV inspect