REQ-10014474
Jul 04, 2024
Spain

Summary

-Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.

About the Role

The Country & Region Operational Excellence Leader will lead initiatives and projects in order to optimize business practices and resources in Countries & Regions.

Your key responsibilities, but not limited to;

  • Represent Countries & Regions team in all PV related process optimization projects.
  • Cooperate with global head patient safety operational excellence and participate all projects of the operational excellence team related to Countries & Regions.
  • Partner with CMO&PS and GDD stake holders for design new processes and their implementation
  • Propose and lead process change initiatives originating from Countries & Regions
  • Assess resources and head counts impact of any proposed projects and processes impacting Countries & Regions team
  • Design metrics for newly implemented project and processes in Countries & Regions
  • Participate and supports Regional Heads and Global PV Manager on projects related to Country Patient Safety processes when needed.
  • Provide guidance to Countries & Regions project coordinator

Desirable skills:

  • Knowledge of Pharmacovigilance regulations, processes, and disciplines.
  • Knowledge of Pharmacovigilance IT applications
  • Capable of managing multiple projects
  • Able to work independently and manage multiple tasks with prioritizing ability
  • Well-organized, excellent time management with respect to priorities and self-management
  • Strong interpersonal skills and expert team player with demonstrated ability to build collaborative cross functional relationships.

Educational Background:

A Sciences degree (for graduates) or equivalent qualification with over 5 years of work experience in pharmacovigilance or drug development.

Languages:

Fluent English (oral and written)

Knowledge of other languages desirable

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here 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.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Operations
Innovative Medicines
Spain
Barcelona Gran Vía
Research & Development
Full time
Regular
No
A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10014474

Country & Regions Operational Excellence leader

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