Senior Patient Safety Specialist

Job Description Summary Primary Location: White City, London, UK Working model: Hybrid working model (which requires 12 days per month in the office) Note: Novartis is not able to offer relocation support for this role. Please only apply if this location is accessible for you. About this role: As a key player in our team, you'll be at the forefront of managing Patient Safety operational processes at the Country Organization. Your mission? To ensure compliance with Novartis global and local procedures, as well as national and international regulations, standards, and guidelines for the pharmacovigilance of Novartis group marketed and investigational products, including both drugs and devices. But that's not all! You will also have the opportunity to mentor and guide less experienced Patient Safety associates, helping them navigate through Patient Safety processes, systems, and operations. Your expertise will be invaluable in shaping the next generation of Patient Safety professionals. Major accountabilities: Manage adverse event reports for all Novartis products from various sources. Oversee the External Service Provider responsible for accurately transcribing and entering data into safety systems to ensure compliance with Novartis Procedures. Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SUSAR, DSUR) to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments. Oversee the daily workload of the Patient Safety associates providing support and guidance and to ensure regulatory GXP and internal timelines are met. Collaborate with other local/global Patient Safety associates to ensure accurate evaluation of safety data. Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third-party contractor, if applicable. Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization. Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements. Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources. Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed. Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections. Role Requirements: Fluent English (both spoken and written) Minimum of 2 years Pharmacovigilance experience. Health Care Sciences Professional, life science degree or equivalent training and experience. Knowledge of national and international regulations for pharmacovigilance Knowledge of pharmacological and medical terminology. Ability to manage multiple projects with different stakeholders. Excellent communications, interpersonal and negotiation skills Quality and focus oriented Computer skills 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 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 Skills Desired:

Databasing, Employee Training, Filing Documents, Management Reporting, Pharmacovigilance, Safety Science

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