Monitors and audits the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.The Senior Vigilance Process Manager drives continuous process optimization and simplification by alignment of relevant stakeholders globally and locally and assessing opportunities for streamlining and automation. The successful candidate will lead /support as Senior SME assigned complex cross functional and PS&PV; projects, including IT projects/systems, which are of a high priority / criticality to the business. Acting as process owner for one or more assigned high complexity/ high impact vigilance process within their functional area:Responsibilities (but not limited to):Lead active surveillance and analysis of emerging regulations, perform impact assessments and drive process changes required to ensure ongoing compliance to global regulatory requirements.Analyze the impact of other Novartis processes and organizational changes on assigned processes.Lead the development, communication strategies and maintenance of respective procedural documents and training materials.Collaborate with other functions to establish requirements for metrics trend analyses, generate knowledge and mitigate any identified risks.Act as Subject Matter Expert / consultant to PS&PV; associates, Country Organizations and other Global Line Functions on regulatory requirements and assigned business processes.Own and maintain relevant PSMF sections and annexes.Maintain the content of Business Continuity Plans for all respective processes, including IT applications for Key Business Processes.Education:PhD, PharmD, MSc degree or Life sciences degree or equivalentProfessional requirements:Minimum 6-8 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable.Leadership and (matrix) management experience.Ability to lead global and cross-functional work groups and deliver cross-functional initiatives in a matrix environment,deal and interact with a wide variety of people at all levels.Strong organizational, analytical and project management skills.Strong negotiation and communication skills and ability to operate effectively in an international, matrix environment#J-18808-Ljbffr
