Vigilance Process Manager - Clinical Trials | U-628

Vigilance Process Manager - Clinical Trials | U-628

27 mar
|
Novartis
|
Barcelona

27 mar

Novartis

Barcelona

In this role, you will develop, monitor and optimizes pharmacovigilance processes and associated metrics related to serious adverse event reporting in clinical trials 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

- Act as subject matter expert during audits and inspections





Minimum requirements



What you’ll bring to the role:





- Have a degree in Lifesciences

- Fluent English

- Minimum 4 - 7 years of experience in the pharmaceutical industry, particularly clinical safety.

- Experience in project management and demonstrated ability to lead work groups in a matrix environment.

- Knowledge of US and European Clinical Trials regulations related to Safety / PV

- Experience of leading process improvement initiatives.

- Ability to deal and interact with a wide variety of people at all levels.

- Strong stakeholder management and alignment competencies is required

- Strong organizational skills.

- Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions

- Cross-cultural awareness





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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