Senior Process Governance

Summary Develop and implement effective procedural updates and training strategies in line with the Patient Safety and Pharmacovigilance PS PV needs and regulatory expectations Oversee Process Governance and Training Excellence PG TE processes and identify areas of improvement and streamlining Work with leaders and process owners across PS PV to identify change management needs as it relates to process changes Major accountabilities Implement the PG TE operational strategy and standards across PS PV Act as a subject matter expert SME for change management and support Lead SMEs Process Owners in the development of procedural document training strategies for process change proposals Deputize for Process Management Committee PMC Chair and Procedural Training and Governance Board PTGB representative as needed Drive continual simplification and improvements for efficiency in the Training and Procedural Governance Processes Lead integration workstreams during mergers spin-off and acquisitions as the PG TE representative Work with Process Owners and SMEs to develop implement document and ensure appropriate applicabilities of individual strategies for the respective process updates Establish and maintain functional training infrastructure within the Learning Management System and all required processes to allow optimized training of all PS PV associates Act as a subject matter expert on process governance change management and training during audits and inspections e g FDA and EMA lead the preparation of responses to findings and the development and implementation of corrective and preventative actions Maintain training compliance oversight including presentation to relevant oversight boards Collaborate with QMS system owners to ensure effective management of procedural and functional trainings within the systems impacting PG TE As a PG TE process owner Own the content and lead the updates for the Adverse Event corporate training Ensure alignment of all PG TE processes within both corporate and GDD standards Actively surveil and analyze emerging regulations perform impact assessments and drive process changes required to ensure timely implementation and ongoing compliance of owned process to global regulatory requirements Lead the development and maintenance of PG TE procedural documents including all required functional trainings and ownership of relevant PSMF sections and annex Key performance indicators Implementation of strategies which result in a measurable increase in the efficiency of the process by which change is managed Implementation of strategies which result in a measurable increase in the quality of procedural documents and the time required to achieve roll out Processes and procedural documents that are compliant with worldwide regulatory requirements and Novartis policies Minimum Requirements Work Experience Minimum 7 years of experience in the pharmaceutical industry particularly pharmacovigilance Leadership and matrix management experience Ability to lead and deliver cross-functional initiatives in a matrix environment Strong organizational and project management skills Strong negotiation and communication skills and ability to operate effectively in an international matrix environment Ability to lead global and cross-functional work groups deal and interact with a wide variety of people at all levels Excellent document writing skills Experience of working with and supporting a team ability to coach and mentor Critical Negotiations People Challenges Operations Management and Execution Collaborating across boundaries People Leadership Skills Clinical Trial Databases Employee Training Process Governance Governance boards Pharmacovigilance Project Management Reporting Safety Science Team Management Languages English Skills Desired Clinical Trial Databases Employee Training Pharmacovigilance Reporting Safety Science Team Management Waterfall Model