Summary

In collaboration with the global patient safety and local leadership, establish and drive Patient Safety (PS) strategy and operational excellence at country level, in compliance with the national and international regulations/standards/guidelines and corporate procedures, for all marketed and investigational products - drugs and medical devices - under the responsibility of all Novartis companies and divisions. As CPSH in a large country with high regulatory demands and visibility, head the local PS department and ensure the oversight of the quality management system for the PV system at local level, in collaboration with the Quality Assurance (QA) function.
As a senior member in the country, influence local/global strategies to promote consistency and alignment between global and local PV-related processes and activities to meet local/global regu-latory requirements. Supports the global/ regional talent development strategy by coaching and mentoring less experienced PS associates.

• In collaboration with the Regional Head (RH), provide key leadership skills based on expertise to the country to meet the strategic vision and regulatory requirements necessary in a large and/or complex country with high regulatory requirements. Key member in the country organization in demanding local organization that has high commercial and regulatory visibility. Key member of the local leadership team or influencing local leadership team to assure the country is meeting its regulatory obligations to the local health authority.
• As defined by local regulations 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.
• Act as the CPSH for all Novartis divisions and group companies. CPSH may delegate the activities to a deputy (CPSH Deputy) but the ultimate responsibility remains with the CPSH. Delegation should be clearly documented.
• Ensure oversight of the structure and performance of Novartis PV System at local level
• Ensure access to all information sources maintained to oversee structure and performance of the PV system at local level.
• Monitor internal compliance for local processing and external compliance (regulatory reporting) according to defined timelines. Ensure that locally delayed safety cases or aggregate reports are properly captured, investigated and root causes addressed through any corresponding corrective/preventative action. Notification and escalation of any late case/submission to Pharmaco-device vigilance Compliance (PVC) and to QPPV/Countries & Regions.
• Monitor and assess the performance and productivity of PV 3rd parties in line with the applicable regulations, agreements and standard operational/ working procedures in place. In collaboration with QA and Vendor Management functions, ensure corrective and/or preventive actions are implemented in case contractual commitments are not met, as applicable.
• 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. Ensure Novartis tools/systems configurations are in line with the specific local requirements to guarantee that the Country Organization receives all the safety information needed to meet local legislation (National Health Authority, Ethic Committees, etc.).
• In collaboration with Regulatory Affairs (RA), ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities; ensure alignment with Global Line Functions/ QPPV office in all safety-related responses, as applicable.
• In cooperation with the QA applicable groups, 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. Contribute as Pharmaco-device vigilance SME, in other internal Novartis audits and/or third-party audits, as applicable.
• As a senior member of QPPV-CPSH network, proactively contribute for the continuous monitoring and awareness of any emerging safety concerns at local level affecting the safety profile of the medicinal products for which Novartis group of companies MAHs hold authorizations. Collaborate together with RA in the implementation of urgent regulatory actions at country level, as required.
• 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