Vigilance Process Manager
Patient Safety & Pharmacovigilance
Location
Barcelona | Spain
Job description
About the Role
Location: Barcelona, Spain (Hybrid)
In this global role as 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 mono-functional projects to ensure compliance to global regulatory requirements with maximum efficiency.
Your responsibilities will include, but are not limited to:
• Driving continuous process improvement and assessing opportunities for streamlining and automation.
• Leading and/or supporting transformational initiatives, including IT projects/systems and process enhancements, in alignment with the company and department strategy.
• Leading the review of emerging worldwide regulations, performing impact assessments, and driving process changes required to ensure ongoing compliance to global regulatory requirements.
• Authoring and maintaining the assigned processes and the associated procedural documents.
• Mentoring and training new starters and associates from other Global Line Functions and developing and maintaining training material and communications for Novartis and third-party associates.
• Collaborating with other functions to monitor regulatory compliance as well as compliance to internal requirements, measuring effectiveness and implementing mitigation strategies when required.
• Acting as Subject Matter Expert / consultant to other global and local functions on regulatory requirements and assigned business processes.
• Acting as a subject matter expert during audits and inspections (e.g. FDA and EMA), leading the preparation of responses to findings and the development and implementation of corrective and preventive actions in alignment with the company strategy.
• Leading and/or supporting as business representative during mergers, spin-offs and acquisitions.
• Representing Novartis externally as a subject matter expert ad-hoc for the respective area of expertise.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential Requirements:
• Fluent English (Both Spoken & Written)
• PhD, PharmD, MSc degree or Life sciences degree or equivalent
• Significant medical device experience (Preferably but not necessarily on device vigilance / post-market surveillance) and/or
• Significant Pharmacovigilance experience beyond operational tasks, a demonstrated track of working at process/system-level
• Experience of leading process improvement initiatives.
• Experience in project management and demonstrated ability to lead work groups in a matrix environment.
• Strong analytical and organizational skills and ability to work autonomously
• Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions
Desirable Skills:
• Additional languages
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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