Sr. Manager Country Patient Safety Resp
Novartis
- Warszawa, mazowieckie
- Stała
- Pełny etat
- Cluster Lead Responsibility - Poland, Czechia, Slovakia, Estonia, Latvia, Lithuania.
- Lead pharmacovigilance activities in the Sandoz affiliate and the assigned Cluster, in the context of the Sandoz Pharmacovigilance System, patient safety operating model, and associated quality system, to ensure that local safety procedures are comprehensive, effective, compliant and well embedded in the cross-functional and global-regional-local environment.
- Mentor Patient Safety Staff in the assigned Cluster, provide leadership for Patient Safety personnel in a dotted line relationship, with vision and guidance and act as responsible manager for any day to day issues that require attention of the Senior manager and Cluster Lead. Develop staff, with involvement in hiring and HR processes in collaboration with the assigned line manager.
- 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.Role RequirementsOur requirements:
- Education (minimum/desirable): Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training, and experience.
- Certified level of written and spoken English.
- Good working knowledge of local language (Polish).
- Knowledge of other languages (desirable).
- 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.