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Job Description Summary
Location: Barcelona or Madrid, Spain
Type: Hybrid working, #LI-Remote.
As a Vigilance Process Manager, you will be responsible for the end-to-end management of assigned pharmaco- and devices vigilance processes across Novartis and leadership of cross functional and Patient Safety (PS) & Pharmacovigilance (PV) projects to ensure compliance to global regulatory requirements with maximum efficiency.
Job Description
KEY RESPONSIBILITIES
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Drive continuous process improvement through by alignment of relevant stakeholders globally and locally, assessing opportunities for streamlining and automation.
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Lead assigned complex cross functional and PS & PV projects and support/deputize for transformational projects led by Senior Vigilance Process Managers / Vigilance Process Leads, including IT projects/systems, leading enhancements in alignment with the company and department strategy.
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Collaborate closely with the product owner and product team, to ensure that the product meets the required standards and is fit for its intended purpose. This involves providing expertise in process management, identifying, and mitigating risks, ensuring compliance with relevant regulations, and facilitating continuous improvement
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Lead active surveillance and impact assessments on emerging regulations and drive process changes to ensure ongoing compliance to global regulatory requirements.
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Analyse the impact of other Novartis processes and organizational changes on assigned processes.
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Collaborate with other functions to monitor regulatory compliance as well as compliance to internal requirements, measure effectiveness and implement mitigation strategies when required.
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Act as Subject Matter Expert / consultant to PS & PV associates, Country Organizations and other Global Line Functions on regulatory requirements and assigned business process.
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Act as a subject matter expert during audits and inspections (e.g. (Food and Drug Administration FDA and European Medicines Agency (EMA)), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions in alignment with the company strategy.
ESSENTIAL REQUIREMENTS:
Education: PhD, PharmD, MSc degree or Life sciences degree or equivalent
Languages: Fluency in English. Knowledge of other languages desirable.
Experience/Professional requirement:
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Minimum 4-6 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable. (Experience in Clinical Development with an interest in PV will be considered)
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Experience of leading process improvement initiatives.
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Experience in project management and demonstrated ability to lead work groups in a matrix environment.
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Strong analytical skills
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Strong organizational skills and ability to work autonomously
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Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions.
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Ability to mentor and coach.
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Quality focus
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Databasing, Employee Training, Management Reporting, Pharmacovigilance, Safety Science, Waterfall Model
