Jun 24, 2022

Job Description

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 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 maintain procedural documents,
training materials, and communications or, in some
instances, lead and oversee 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 in to the root cause and implementation
of corrective and preventative actions (CAPAs) is
performed and the effectiveness of the actions
• Driving continuous process optimization and
• Collaborate 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
• Act as a subject matter expert during audits and
inspections (e.g., EMA, FDA) and lead the
preparation of responses to findings and the
development and implementation of CAPAs

What you will bring to the role:

The ability to collaborate across boundaries and lead cross-functional working group. 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!

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

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements


PharmD, MSc degree in life sciences or equivalent.


• 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
• Ability to lead global and cross-functional work
groups; 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

• Experience working within in a multinational
pharmaceutical company
Global Drug Development
Barcelona Gran Vía
Research & Development
Full Time
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Senior Vigilance Process Manager

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