Senior Vigilance Process Manager

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

measured.
- Driving continuous process optimization and

simplification
- 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

inspections (e.g., EMA, FDA) and lead the

preparation of responses to findings and the

development and implementation of CAPAs

expert; possible participate and/or join external

conferences and networks for respective area of

expertise.
- Lead 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 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**

**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 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

Desirable:

- Experience working within in 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