Clinical Safety Science Lead

Location: Barcelona Spain (onsite) 3 days working from the office and 2 days working from home.

Introduction

Were building out a bestinclass team to support R&D as well as routine care setting 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

Digital health the point at which healthcare technology data and analytics converge is the subject of great promise with the World Health Organisation believing it has the potential to improve health for everyone. At AstraZeneca weve been working hard to make this a reality with the years of experience we have accumulated enabling us to now embed digital health at scale across R&D. To achieve our goal of improving patient experience and outcomes AstraZeneca has Digital Health as one of the top 4 strategic priorities for the company.

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 themarket including enabling their utilisation in clinical studies for investigational medicinal products or in a healthcare setting when on themarket.

Accountabilities

• Provide ongoing leadership and safety and clinical subject matter expertise to device and digital projects/products. Ensures 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 programs design and development

  • Contribute to Risk Management File (RMF) through the analysis of hazard assessments

  • Provide clinical signoff

• Contribute to developing clinical device and/or digital documents

  • Leading the creation and update of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) based on postmarket surveillance (PMS) data

  • Lead Post Market Surveillance such as authoring the PMS Plan

• Responsible for carrying out all vigilancerelated activities for Software as a Medical Device (SamD) including receipt of postmarket data vigilance data analysis actionaling post market clinical followup plan field safety corrective actions trend reporting and/or medical devices reporting.

• Ensure Clinical Safety Science contribution is aligned with regulations.

• Review analyse and interpret safety data obtained to lead device and digital development

• Take accountability and lead resolution of safety issues and mediate crossfunctional agreement related to assigned devices or digital assets.

• Participate in crossfunctional process improvement or other initiatives related to digital and devices

• Contribute to the generation of Evinovas position on innovative use of digital health solutions and medical devices in medicinal product development and post market activities

• 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

• Actively participate in SamD audits & notified body assessments supporting demonstrateion of compliance with regional requirments

• Provide subject matter expertise to establishment review approval and maintenance of relevant clinical & safety procedures within the SaMD Quality Management System (QMS)

• Maintain oversight of medical device digital health regulations and local requirements that impact patient safety and/or require implementation

• Act as the primary point of escalation for any risks and issues identified relevant to the assigned projects/products

• 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

• 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

• Combination of academic training and practical experience in device and/or digital development experience or related knowledge/experience. This may consist of:

  • Masters degree in a related discipline plus 8 years practical clinical experience OR

  • Bachelors degree in a related discipline plus 5 years clinical practical experience

• Extensive knowledge of digital health technologies in drug development.

• Extensive knowledge of devices utilised to administer medicine or monitor patients.

• Previous demonstrated experience of regulated drug and/or device development or equivalent and experience with major Health Authority interactions (US or ExUS) particularly in the field of safety science

• Professional experience in clinical development patient safety and/or quality management systems relating to medical devices and device constituents

• Knowledge and understanding of global clinical and postmarket safety requirements and an ability to balance with industry standards to achieve business goals.

• Demonstrated competencies of strategic thinking strategic influencing innovation initiative leadership and excellent oral and written communication skills.

• Strong communication negotiation and problemsolving skills.

• Ability to work effectively in crossfunctional teams and manage multiple priorities.

• Excellent organizational and project management skills.

• Strong attention to detail and ability to work independently.

• Creative innovative and solutionfocused

• Curious embraces new ways of problem solving new ideas and new ways of working

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industryleading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.