Clinical Safety Science Lead

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

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 utilisation in clinical studies for investigational medicinal products or in a healthcare setting when on the market.

Accountabilities

1. Lead and be responsible for the medical and scientific input to the device and/or digital program’s design and development.
2. Contribute to Risk Management File (RMF) through the analysis of hazard assessments.
3. Provide clinical sign-off.
4. Contribute to developing clinical device and/or digital documents.
5. Lead the creation and update of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) based on post-market surveillance (PMS) data.
6. Lead Post Market Surveillance, such as authoring the PMS Plan.
7. 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.
8. Ensure Clinical Safety Science contribution is aligned with regulations.
9. Review, analyse and interpret safety data obtained to lead device and digital development.
10. Take accountability and lead resolution of safety issues and mediate cross-functional agreement related to assigned devices or digital assets.
11. Participate in cross-functional process improvement or other initiatives related to digital and devices.
12. Contribute to the generation of Evinova’s position on innovative use of digital health solutions and medical devices in medicinal product development and post market activities.
13. Actively participates in Issue Management Team where investigation of an incident requires assessment of the safety or performance of a medical device or device constituent; responsible for assessing issues/cases utilizing clinical & medical expertise to determine potential impact to patients/users.
14. Actively participate in SamD audits & notified body assessments, supporting demonstration of compliance with regional requirements.
15. Maintain oversight of medical device, digital health regulations, and local requirements that impact patient safety and/or require implementation.
16. Act as the primary point of escalation for any risks and issues identified relevant to the assigned projects/products.
17. Work with internal teams to monitor the overall performance of processes & technology within the assigned area. Track & monitor agreed key performance indicators, oversee the delivery of Corrective and Preventative Actions to time and Quality, and act on data or trends identified through the Quality and Risk Management processes.
18. Serve as SME to provide operational and/or strategic safety input and guidance to Evinova clients in their utilization of digital and device development Evinova cross functional teams.

Education, Qualifications, Skills and Experience

Essential for the role

1. Combination of academic training and practical experience in device and/or digital development experience or related knowledge/experience. This may consist of:
1. Masters degree in a related discipline, plus 8 years practical clinical experience OR
2. Bachelors degree in a related discipline, plus 5 years clinical practical experience.