Summary
About the Role
Major activities
Drive continuous process improvement by alignment of relevant stakeholders globally and locally, assessing opportunities for streamlining and automation.
Lead assigned PS&PV projects and support higher complexity/criticality projects led by (Senior) Vigilance Process Managers, including IT projects/systems, in alignment with the company and department strategy.
Act as process owner / deputy process owner for assigned vigilance processes:
- Support active surveillance and analysis of emerging regulations, perform impact assessments, and drive process changes to ensure ongoing compliance to global regulatory requirements.
- Author and maintain the assigned processes and the associated procedural documents.
- Mentor and train new starters in PS&PV and participating in the creation and maintenance of training material and communications for Novartis and third-party associates.
- Act as Subject Matter Expert / consultant to PS&PV associates, Country Organizations and other Global Line Functions on regulatory requirements and assigned business process.
- 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.
Role requirements
- PhD, PharmD, MSc degree or Life sciences degree or equivalent
- Minimum 2-4 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable.
Skills
- Experience of leading working groups.
- Procedural document writing experience.
- Good analytical skills / proven ability to work with data.
- Strong presentation and communication skills, and ability to operate effectively in an international environment and across functions.
- Strong organizational skills
- Ability to mentor and coach
- Quality focus
Languages
- Fluency in English. Knowledge of other languages desirable.
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? https://www.novartis.com/about/strategy/people-and-culture
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