Job Description
The purpose of the role is to establish and drive the 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, head the local PS department will ensure the oversight of the quality management system for the PV system at local level, in collaboration with the local leadership/local/regional Quality Assurance (QA) function.
Single point of contact: 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]
Country Patient Safety Head (CPSH): 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]. Key member of the local leadership team and/or influencing local leadership team to assure the country is meeting its regulatory obligations to the local health authority. Stakeholder management at a senior level in the local organization and at the global level in PS.
Management of Safety Information: Ensure oversight of the structure and performance of Novartis PV System at local level, in order to promote, maintain and improve compliance.
Documentation: Ensure access to all information sources maintained to oversee structure and performance of the PV system at local level.
Monitoring internal and external compliance of Safety Reports: 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 Pharma-co-device vigilance Compliance (PVC) and to QPPV/Countries & Regions.
Oversight of local PV third parties working on behalf of Novartis: 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.
Regulatory Intelligence: Drive the local impact assessment of new local pharmacovigilance-related legislation and provide support to Global PS organization on local PV matters and local change impact.
Compliance with Local Legislation: Ensure the local Pharmaco-device vigilance requirements are met. Ensure Novartis tools/systems configurations are in line with the country-specific requirements to guarantee that the Country Organization receives all the safety in-formation needed to meet local legislation (i.e. National Health Authority, Ethic Committees, etc.)
Health Authority Requests: 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
Audits and Inspections: In cooperation with the QA applicable groups, manage any local Pharmaco-vigilance inspection and/or Pharmaco-device vigilance audit and proactively, co-operate 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 required.
EUQPPV-CPSH Network: Contribute for the continuous monitoring of any emerging safety concerns at local level affecting the safety profile of the medicinal products for which Novar-tis group of companies MAHs hold authorizations. Collaborate together with RA in the implementation of urgent regulatory actions at country level, as required.nb
POP Governance: Ensure the country oversight of Patient Oriented Programs (POPs) held at local level, in line with Novartis procedures and applicable regulations/ standards/ guide-lines.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Experience
Minimum requirements
Minimum 5 years’ experience in drug-safety or phar-macovigilance (preferred) and/ or experience in pharmaceutical industry;
Good knowledge of regional and local requirements relating to PV;
Working knowledge of PV-processes, covering compli-ance, databases, procedures, QA, training;
Ability to lead, plan and prioritize activities simulta-neously;
Ability to manage and provide guidance and direction to team members;
Strategic thinking;
Quality and focus oriented;
Good communication and networking skills;
Computer/IT systems literacy
Education
Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
Language
Certified level of written and spoken English
Good working knowledge of local language
Knowledge of other languages (desirable)
Apply via :
sjobs.brassring.com
