LOCATION: Barcelona, Spain
ROLE TYPE: Hybrid working. #LI-Hybrid
The Patient Safety Manager monitors and audits the company’s drug, biologics and medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports.
They participate in the resolution of any legal liability and in complying with government regulations. This includes ensuring accurate receipt, maintenance and assessment against product labelling. Reporting events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports.
They also provide trending and safety signal detection and assessment and support all clinical trial activity and post marketing.
About the Role
Major accountabilities:
* 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
* Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements.
* In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions.
* Act as a subject matter expert during audits and inspections (e.g. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)), lead the preparation of responses to findings and the development and the implementation of corrective and preventative actions.
* Measure effectiveness of actions taken
Key performance indicators:
* Adherence to Novartis policy and guidelines
* Operational risk mitigation and audit/inspection findings
* Quality and timely reporting of KPI and safety reports/updates
For this role we are searching for applicants with experience of c ase processing from Pharmacovigilance (PV) perspective at a local level.
They will also need to:
* Have a systematic approach
* Have experience of GxP documentation practices
Languages :
Fluency in both Spanish and English are essential for this position
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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