摘要
ROLE TYPE: Hybrid working. #LI-Hybrid
The Patient Safety Manager is responsible for operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for the vigilance of Novartis group approved, marketed and investigational products (incl. drugs, food supplements and medical devices).
They also support the Country Patient Safety Head (CPSH) in the implementation of Patient Safety (PS) strategy at country level.
About the Role
Major accountabilities:
- To be the accountable for specific operational vigilance process(es) at the Country Organization
- Ensure oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information to Local Health Authorities (LHA) according to regulatory requirements and Novartis procedures.
- Interact and exchange relevant safety information with Health Authorities, other functional groups, third-party contractors, and PS associates.
- Ensure local PS-related Risk Management Plan (RMP) commitments are executed and properly documented
- Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.
- Provide scientific expertise during review of all Phase IV Clinical Trial and Non-Interventional Studies (NIS) protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.
- Ensure timely preparation and submission of KPI reports on Adverse Event (AE) reporting or AE follow-up including identification of root cause(s) e.g., for late reporting to HA, missed or delayed follow-up attempt, development and implementation of corrective and preventative action(s) as needed.
- Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections.
Key performance indicators:
- Organisation, quality management and efficiency of vigilance processes
- Country Organization AE reporting compliance
- Internal and external customer satisfaction
- Compliance with RMP commitments
Minimum Requirements:
For this role we are searching for applicants with experience of case processing from Pharmacovigilance (PV) perspective at a local level.
They will also require the following:
- Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience
- Project management skills
- Excellent communications and negotiation (networking) skills
- Quality focused and results oriented
- 2 years’ experience in pharmacovigilance or equivalent field
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
