Medical Safety Lead - CRM

Job description

Salary Range: €69,000.00 - €128,100.00 Band Level 5 Job Description Summary Ready to shape the safety of medicines used by millions worldwide? As a Medical Safety Lead in Cardio Renal Metabolism, you will combine clinical insight and scientific expertise to evaluate safety data, detect signals, and guide critical decisions across the product lifecycle. Working with global cross-functional teams, you will play a pivotal role in helping millions of patients with serious diseases. Job Description Location: Barcelona, Spain Working Model: Hybrid (12 days/month in office) #LI-Hybrid (Note: this role is also advertised in London, UK. If you are interested in that location, please apply on requisition number 10085146) Relocation Support: Novartis is unable to offer relocation support - please only apply if the location is accessible to you. Key accountabilities: Monitor clinical safety data, including literature, case reports, and signal detection activities Drive the application of AI-enabled solutions to simplify and enhance pharmacovigilance processes, leveraging knowledge of AI agents and their use in medical safety. Conduct medical assessment of individual adverse event cases and ensure accurate evaluation Identify, evaluate, and monitor safety signals using single-case and aggregate data Contribute to responses for regulatory authorities and healthcare professional safety inquiries Support preparation of core safety documents, including clinical overviews and summary reports Provide medical input to aggregate safety reports and regulatory submissions Collaborate cross-functionally to integrate safety insights across global development teams Guide adverse event coding, causality assessment, and interpretation of clinical safety data Essential Requirements: Degree in Pharmacy, Nursing, Pharmacology, Life Sciences, or a medical degree (medical degree required for roles involving medical review of individual case safety reports) Fluency in written and spoken English At least 3 years’ experience in drug development within a pharmaceutical company (including 2 years in patient safety at an operational or medical position is preferred) Experience in clinical trial methodology, regulatory requirements, scientific methodology, and statistical principles, including authorship of scientific publications Strong ability to analyse, interpret, and clearly communicate clinical safety data to diverse stakeholders Experience in safety and cross-functional issue management (e.g., regulatory inquiries, compliance issues, labelling updates, and risk escalations) Proven experience contributing to safety reports and regulatory documentation Desirable Skills Experience of using professional AI tools and agents for process improvement is strongly preferred Experience managing clinical safety issues If you are passionate about patient safety and want to make a meaningful impact at scale, we encourage you to apply and join us in reimagining medicine together! Benefits & Rewards At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: EUR 69,000 to 128,100 The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process. Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the recruitment process, please let us know. Skills Desired Clinical Trials, Medical Information, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Science