Location: Barcelona, Spain (on-site) 3 days working from the office and 2 days working from home.

Working with the Processes and Partnership (P&P) leads in PV Processes, Partnerships and Contracts group in Patient Safety Centre of Excellence, CMO, the Associate Director, Lead SIRC Coordinator is responsible for leading the responsibilities for the management of all SIRC operational activity, including but not limited to day to day Pre­ SIRC and SIRC meeting activity, system automation activity including development, implementation and mangement of an automated solution.

The SIRC Lead is accountable to develop relationships across Patient Safety, Patient Safety Centre of Excellence, and other relevant cross-functional areas of AZ to facilitate the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.

Leads cross functional process improvement activity as it relates to the SIRC process and any relevant interfaces and serves as SIRC process owner. Coordinates TA specific Safety Information Review Committee (SIRC) meetings. These meetings usually involve signal evaluation including but not limited to causality assessment and project safety decision related activities. The SIRC Coordninator is responsible for the planning and follow-up of both scheduled and ad-hoc SIRC meetings, including circulation of pre-reads and minutes of the SIRC meetings, maintaining a database for the SIRC for archving of minutes. The SIRC is chaired by the designatated PS representative for the product.

Typical Accountabilities

• Coordination and ownership of the lifecycle management of nominated processes (e.g. SIRC process) and partnerships, enabling business continuity and compliance.
• Leads SIRC Coordinator responsibilities as single point of contact for all pre SIRC and SIRC meeting matters
• Oversees Junior SIRC coordinator(s) activities, including training and mentoring in SIRC operational activity.
• Serve as the delegate, where appropriate, for the PSPP&C Leads
• Acts as SIRC lisaion with other functional areas whereby there is interface activity for process and system related SIRC operations.
• Leads projects in collaboration with RDI to deliver/manage technical solutions supporting the lifecycle of the SIRC
• process.
• Represents the SIRC process area in cross functional teams to ensure effective interface with SIRC operations.
• Handles all logistic details including agendas, invitations, circulation of pre-read materials and meeting minutes, appropriate archival of documentation.
• Proficient in SIRC processes to support patient safety teams
• Maintains credible records of all meetings and decisions that can be subject to internal or external audits.
• Develops and maintains relevant information assets such as SharePoint site, and tools used by SIRC members that enable effective sharing, re-use, accessibility, and quality.
• Supports the overall improvement of enabling activities relating to conduct of SIRC meetings; including troubleshooting problems & developing solutions.
• Provides training to SIRC Chairs, SIRC Members, relevant stakeholders in CMO, partners, and other functional groups
• Lead the development and/or enhancement of standards or techniques in order to improve the quality, compliance and efficiency of deliverables for the overall group.
• Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
• Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes and partnerships.
• Other duties as deemed necessary to support the ESB operational Lead, the PS CoE, and CMO.
• Ensures that all work is carried out with regards to AstraZeneca standards and external regulations
  

As the following relate to SIRC/Safety Governance:

• Identify opportunities for and drives the enhancement of existing SIRC process through knowledge of internal and external environment.
• Utilize safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
• Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca’s pharmacovigilance and regulatory LTO safety governance responsibilities
• Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance support to safety and regulatory teams and submissions.
• Contribute to the overall management and oversight of the Pharmacovigilance Quality System.
• Where applicable, develop and improve reporting tools and analysis processes and technology.
• Performing the monitoring, analysis and trending of data.
• Identify issues and risks and propose options to mitigate them.
• Monitor, interpret and validate current, new and changing legislation, and manage the impact of changes.
• Participate and /or support activities for GVP, GCP, GRP and GMP audits/inspections
• Deliver on project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces.
• Seek personal and professional development opportunities, and share knowledge gained in open forums
• May represent AZ on industry bodies
• Contribute to communication and change management activities associated with processes and partnering initiatives.
• Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships
• Working collaboratively to provide expertise and sharing best practices across all regions

Education, Qualifications, Skills and Experience

Essential

• Experience in Safety governance review (SIRC type) meetings
• Experience in senior stakeholder engagement in Safety
• Signal Matters
• Proven competence, with hands-on experience, in coordination of projects/meetings
• Excellent analytical, written and oral communication skills
• Mastery in use of Outlook, SharePoint, Document Management Systems, PowerPoint, Excel programs
• Highly motivated and delivery focused
• Able to work independently with limited direction
• Flexible and adaptable to an evolving environment
• Experience in working across different geographic locations, organizations, and cultures to influence or drive actions in a results oriented fashion

Desirable

• Bachelor’s degree in a scientific discipline, with an understanding of patient safety or pharmacovigilance in bio-pharmaceutical drug development.

• Experience in integrating information across multiple domains

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 industry-leading 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 non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.