.Location: Barcelona, Spain (on-site) - 3 days working from the office and 2 days working from home.
Introduction We're building out a best-in-class team to support R&D as well as routine care settings with digital solutions including digital therapeutics to ensure that our products have the right scientific foundations to provide impactful insights towards better patients' care.
Evinova Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside.
Through our application of science-based expertise, evidence-led rigor, and human experience-driven insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together.
Evinova is a health-tech business within the AstraZeneca Group.
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide.
Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality.
If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
The role The Clinical Safety Science Lead responsibilities include, but are not limited to, providing clinical expert leadership and knowledge to Evinova developed and marketed device and digital solutions.
This individual will act as Clinical Safety Science Lead for assigned projects/products during development and on the market, including enabling their utilization in clinical studies for investigational medicinal products or in a healthcare setting when on the market.
Accountabilities Provide ongoing leadership and safety and clinical subject matter expertise to device and digital projects/products.
Ensure input of suitable medical safety and clinical evidence expertise to the SaMD product design process.
Lead and be responsible for the medical and scientific input to the device and/or digital program's design and development.
Contribute to Risk Management File (RMF) through the analysis of hazard assessments.
Provide clinical sign-off.
Contribute to developing clinical device and/or digital documents.
Lead the creation and update of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) based on post-market surveillance (PMS) data.
Lead Post Market Surveillance, such as authoring the PMS Plan.
Responsible for carrying out all vigilance-related activities for Software as a Medical Device (SaMD), including receipt of post-market data, vigilance data analysis, actioning post-market clinical follow-up plan, field safety corrective actions, trend reporting, and/or medical devices reporting.
Ensure Clinical Safety Science contribution is aligned with regulations.
Review, analyze and interpret safety data obtained to lead device and digital development