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Patient Safety Senior Specialist

Location: London
Company: Novartis Pharmaceuticals
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332112BR Job ID: 332112BR Job Description: 500+ ongoing clinical trials; 160+ projects in clinical development; 80+ major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions. Job Purpose: To support management of Patient Safety processes at Country Organization in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of Novartis group, marketed and investigational products (drugs and devices). Your responsibilities: Your responsibilities include, but are not limited to: • Plan and manage the workload of the Operations team associates to fulfill the regulatory and company requirements for adverse event handling. • Manage the collection, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Oversee the third party contractor activity for accurate and consistent data entry from source documents into safety systems. • Manage the reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments. • Work 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. • Manage the completion of all safety monitoring activities to a high standard • Prepare the submission of 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. • Develop and update training materials for pharmacovigilance and ensure training and oversight of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable. • Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections. • Ensure training and oversight of staff, as applicable. • Manage and maintain efficient Patient Safety electronic filing and archive system. \n\n\n\n Position Title: Patient Safety Senior Specialist Minimum requirements: What you'll bring to the role: • Life science graduate or Health Care Sciences Professional or equivalent education, training and experience • Knowledge of national and international regulations for pharmacovigilance • Knowledge of pharmacological and medical terminology • Excellent communications, interpersonal and negotiation skills • Experience of overseeing the work of others is desirable • Quality and focus oriented You'll receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities. Why consider Novartis? 769 million. That's how many lives our products touched in 2020. 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. Imagine what you could do at Novartis! For the Eighth consecutive year, Novartis been certified a 'Top Employer' in the UK (2014-2021)! Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network We are Novartis. Join us and help reimagine medicine. #LI-NOV = Novartis Job Type: Full Time Country: United Kingdom Work Location: London-West Functional Area: Research & Development Division: Global Drug Development Business Unit: CMO & PATIENT SAFETY GDD Employment Type: Regular Company/Legal Entity: Novartis Pharmaceuticals UK Lt Commitment to Diversity & Inclusion:: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No
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