Associate Director, Patient Safety Processes & Partnerships
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 management 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 Coordinator 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 archiving of minutes. The SIRC is chaired by the designated 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.
* Serves as the delegate, where appropriate, for the PSPP&C Leads.
* Acts as SIRC liaison 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.
* Leads the development and/or enhancement of standards or techniques in order to improve the quality, compliance and efficiency of deliverables for the overall group.
* Identifies opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
* Identifies and promotes 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:
* Identifies opportunities for and drives the enhancement of existing SIRC process through knowledge of internal and external environment.
* Utilizes 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 provides process or compliance support to safety and regulatory teams and submissions.
* Contributes to the overall management and oversight of the Pharmacovigilance Quality System.
* Where applicable, develops and improves reporting tools and analysis processes and technology.
* Performs the monitoring, analysis and trending of data.
* Identifies issues and risks and proposes options to mitigate them.
* Monitors, interprets and validates current, new and changing legislation, and manages the impact of changes.
* Participates and/or supports activities for GVP, GCP, GRP and GMP audits/inspections.
* Delivers on project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces.
* Seeks personal and professional development opportunities, and shares knowledge gained in open forums.
* May represent AZ on industry bodies.
* Contributes to communication and change management activities associated with processes and partnering initiatives.
* Builds relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships.
* Works collaboratively to provide expertise and sharing best practices across all regions.
Education, Qualifications, Skills and Experience
* 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, and 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.
* 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.
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