Job Description

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

Skills Required