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Global Drug DevelopmentJob ID 211867BR Position Title Patient Safety Specialist, Novartis, Denmark Division Global Drug Development Business Unit CMO & PATIENT SAFETY GDD Country Denmark Work Location Copenhagen Company/Legal Entity NOV HLTCR DNK Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description Job Purpose: The purpose of the Patient Safety Specialist role is to support management of Patient Safety operational processes in the Nordic 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). Key Responsibilities: • Manage collection, processing, 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. • Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality. • Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities 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. • 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. • Management and maintenance of all relevant Patient Safety databases. • 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. • Develop and update training materials for pharmacovigilance and ensure training 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, and investigation and Health Authority inspections. • Ensure training and oversight of staff, as applicable. Manage and maintain efficient Patient Safety filing and archive system. About Novartis: Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. In Novartis Group we focus on three areas – innovative medicines (Pharmaceuticals & Oncology), eye care (Alcon) and generics (Sandoz). We have offices in all four Nordic countries and we are approximately 900 associates. Our mission is to discover new ways to improve and extend people's lives. Our vision is to be a trusted leader in changing the practice of medicine. Corporate responsibility is central to how we run our business. We focus our CR work in two key areas: expanding access to healthcare and doing business responsibly. As a global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. Diversity and Inclusion Each of us is different. At Novartis, we aspire to move beyond stereotypes, assumptions and bias to bring these differences together every day. To operate successfully as a global organization, it is essential that our people reflect the rich cultural, ethnic and gender diversity of our markets. Diversity of our workforce enhances customer insight and our ability to meet the needs of patients and other stakeholders. Retaining the most qualified talent adds value to our company, our customers, our employees, our shareholders, our suppliers and the communities in which we live and work. Culture and Values Novartis has a clear mission, focused strategy and strong culture, all of which we expect will support the creation of value over the long term for our company, our shareholders and society. We recognize that our business depends on the creativity, dedication and performance of our associates. We encourage associates to focus on achievement through collaboration and innovation. Our values help guide the choices people make every day, and they define our culture and help us execute the Novartis strategy in line with our mission and vision. Our values and behaviors are: Innovation - by experimenting and delivering solutions Quality - by taking pride in doing ordinary things extraordinarily well Collaboration - by championing high performing teams with diversity and inclusion Performance - by prioritizing and making things happen with urgency Courage - by speaking up, giving and receiving feedback Integrity - by advocating and applying high ethical standards every day Benefits of Working for Novartis: •Competitive Salary •Bonus Scheme for employees on all levels •Pension & Insurance Scheme •“Be Healthy” initiatives to promote associate health and prevent future health issues • Flexible working hours and possibility to work from home ‘I came for the job, I stay for the culture’ #LI-NOV Minimum requirements The ideal candidate will have: •Health Care Sciences Professional (e.g. Nurse, Pharmacist) •Good written and verbal communication skills in Danish and English, experience with other Scandinavian language is plus • Broad pharmaceutical/medical knowledge preferably supported by drug safety or pharmacovigilance know-how. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons. We kindly ask you to apply with an English version of your CV and if shortlisted you can expect a call from an international number.
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