Senior Vigilance Process Manager
hace 5 días
Job Description Summary
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.Job Description 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 equivalent Professional 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 Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could achieve here at Novartis
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to ****** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
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