1000! That's how many DSURs, PSURs, Addendum Statements, and US PADERs we write in a year. In this global role as Senior Vigilance Process Manager, you will develop, maintain, and continuously improve processes for aggregate reporting (DSUR, PSUR, US PADER). Senior Vigilance Process Managers work as part of an international team across five countries, ensuring that our processes are compliant with regulations and internal standards. You will establish processes to monitor the quality and compliance of our aggregate reports and ensure proper investigation and action in case of delays or quality issues.
Your responsibilities include, but are not limited to:Leading the review of emerging worldwide regulations, performing impact assessments, and driving process changes required to ensure ongoing compliance to global regulatory requirements.Developing and maintaining procedural documents, training materials, and communications or, in some instances, leading and overseeing these activities done by less senior process owners.Developing training and communication strategies.Establishing clear processes for tracking regulatory compliance and, in the case of any delays, ensuring investigation into the root cause and implementation of corrective and preventative actions (CAPAs) is performed and the effectiveness of the actions measured.Driving continuous process optimization and simplification.Collaborating with other process owners to ensure alignment and consistency between processes and maximize efficiency.Resolving queries from other functions and Country Organizations (COs) and acting as a consultant to CMO&PS associates and other global line functions on regulatory requirements inspections (e.g., EMA, FDA) and leading the preparation of responses to findings and the development and implementation of CAPAs.Leading as business representative during mergers and acquisitions.Supporting the Vigilance Process Excellence management team with developing and implementing group operational strategy including outsourcing strategies and objectives.What you will bring to the role:The ability to collaborate across boundaries and lead cross-functional working groups. Strong communication skills and knowledge of how to handle critical negotiations. Experience in aggregate reporting (DSUR, PSUR, US PADER or similar) writing or process set-up.
You will receive:Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Novartis?769 million. That's how many lives our products touched in 2020. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives? We believe the answers are found when curious, courageous, and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges. Imagine what you could do 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.
Minimum requirements:Education:PharmD, MSc degree in life sciences or equivalent.
Experience:Advanced English language written and spoken.7+ years in a similar role.Leadership and (matrix) management experience.Ability to lead and deliver cross-functional initiatives in a matrix environment.Strong organizational and project management skills.Strong negotiation and communication skills and ability to operate effectively in an international, matrix environment.Ability to lead global and cross-functional workgroups; deal and interact with a wide variety of people at all levels.Experience of working with and supporting a team; Ability to coach and mentor.Desirable:Experience working within a multinational pharmaceutical company.Division:Global Drug Development
Business Unit:CMO & PATIENT SAFETY GDD
Country:Spain
Work Location:Barcelona Gran Vía
Company/Legal Entity:Novartis Farmacéutica, S.A.
Functional Area:Research & Development
Job Type:Full Time
Employment Type:Regular
Shift Work:No
Early Talent:No
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