[Y-02] Vigilance Process Manager - Aggregate reporting

[Y-02] Vigilance Process Manager - Aggregate reporting

27 mar
|
Novartis
|
Barcelona

27 mar

Novartis

Barcelona

250! As Vigilance Process Manager you will improve the daily work of 250 Novartis and third party associates by enduring a simple and efficient processes for preparation of aggregate reports.



In this role, you will develop, monitor and optimize vigilance processes and associated metrics for preparation of aggregate reports (e.g. DSUR, PSUR, US PSR or similar) ) to drive performance and quality and ensure compliance with the worldwide regulatory requirements.



To learn more about Novartis Spain, visit: http://www.novartis.es/



Your responsibilities include, but are not limited to:





- End to end management of assigned pharmacovigilance processes across Novartis Divisions



- Responsible for ensuring compliance to global regulatory requirements with maximum efficiency

- Lead assigned cross functional patient safety projects

- Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally

- Develop and maintain training material and communications for Novartis group and third party associates

- Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements

- Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases)

- Analyze the impact of other process and organizational changes





Minimum requirements



What you’ll bring to the role:





- 4-5 years relevant experience in pharmaceutical industry (experience in the area of aggregate reporting is a must)

- English fluent and preferably Spanish

- Have a degree in Lifesciences

- Cross-cultural awareness

- Experience of leading process improvement initiatives

- Experience in project management and demonstrated ability to work in a matrix environment; ability to deal and interact with a wide variety of people at all levels of the organization

- Strong organizational skills; strong negotiation, presentation and communication skills





You’ll receive:

Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexible working hours



Why Novartis

927 million. That’s how many lives our products touched in 2017. 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.



We are Novartis. Join us and help us reimagine medicine.



Division



Global Drug Development



Business Unit



CMO & PATIENT SAFETY GDD



Country



Spain



Work Location



Barcelona



Company/Legal Entity



Novartis Farmacéutica, S.A.



Functional Area



Research & Development



Job Type



Full Time



Employment Type



Regular



Shift Work



No

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