Country Patient Safety Responsible Specialist
Novartis
- Budapest
- Állandó
- Teljes munkaidő
Collaborate closely with local Croatian QPPV.Influence the affiliate organization as a key member of the affiliate organization with high visibility, to promote a thorough understanding of the pharmacovigilance system, adherence to safety requirements for local activities.Ensure the seamless flow of safety relevant information, within the affiliate, with local business partners and with regional hubs and 3rd party vendor in accordance with the Sandoz patient safety operating model.Maintain awareness on safety profiles of Sandoz products and provide safety expertise and support for all marketed and investigational products - drugs and combination products - to other functions in the affiliate.Establish or participate in oversight mechanisms on safety activities, specifically those outsourced to vendors on behalf of the affiliate (local activities, such as in patient-oriented programs as well as core safety activities, and core safety activities, such as case handling and periodic report generation).Participate in the maintenance of the local quality management system, including training, records management, regulatory intelligence, audit and inspection readiness, in collaboration with local, regional and global functions, business partners and vendors.Your responsibilities include, but not limited to:
- Build strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director Patient Safety HUB/ Associated Director Patient Safety HUB and 3rd party vendors.
- In collaboration with the Sandoz regional Hubs and the 3rd party vendor operational hubs, ensure that communication flows for safety processes including any local sources of safety data and safety issues are identified and implemented.
- Ensure the local management of adverse event information, with the following aspects:
- Maintaining oversight on case content and reporting.
- Maintain awareness of product complaints received in the affiliate, ensure exchange and reconciliation of product complaints associated with adverse events.
- In collaboration with 3rd party vendor, identify the local journals required for screening, maintain overview on search results specifically any potential safety signals or aspects relating to benefit/risk.
- 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.
- Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks. Ensure the country oversight of implementation of Post Authorization Safety Studies and additional Risk Minimization Measures at local level.
- Build relationships with health authorities, industry associations, healthcare professionals, patients and caretakers.
- Local Procedures: Ensure the local Pharmacovigilance requirements are met. Identify specific requirements that may not be covered by global procedures and communicate to the Sandoz regional hub. Where required, implement local procedures to supplement PS global procedures and to ensure compliance national requirements.
- Collect and share relevant metrics for local business volumes and performance. Participate in governance meetings at regional and global level to have oversight on the performance of the PV system.
- Audits and Inspections: In cooperation with the 3rd party vendor, QA and other applicable groups, maintain audit/inspection readiness with the support of regional hubs and 3rd party vendor and manage any local Pharmacovigilance audit/inspection.
- Participate or maintain awareness of key governance meetings in the affiliate to stay informed of important developments in the affiliate that may have an impact on the conduct of safety activities.
- Build relevant external interfaces with local distributors, license partners, vendors to collaborate on day-to-day matters and oversee the adherence to safety relevant obligations of contracts and PV agreements.
- Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience
- Fluent Hungarian and English
- Minimum 2 years' experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry.
- Demonstrated leadership and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry.
- 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 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.