Associate Director, Patient Safety Technical Solutions - Reporting

Job Title: Associate Director Patient Safety Technical Solutions Reporting

Global Career Level: E

Introduction to role

The Patient Safety (PS) Technical Solutions Team part of Operations Technology & Analytics in Global Patient Safety (GPS) is responsible for managing the information assets and systems owned by the Chief Medical Office (CMO). This team ensures these assets are effectively supported and governed across the enterprise while deploying system analytics and informatics expertise to meet GPSs scientific business and compliance needs.

Reporting to the Director of PS Technical Solutions the Associate Director provides Pharmacovigilance (PV) subject matter and technical expertise across AstraZenecas enterprise businesscritical PV systems. The role holder works within a team of peers all of whom employ an indepth knowledge of business requirements PV and regulatory policies industry standards and trends as well as an understanding of the related assets to support effective governance maintenance and development of the enterprisewide systems that enable PV compliance and reporting. The role holder will work within the PS Technical Solutions Team and will directly support the design development implementation continuous improvement and/or optimal utilization of AZ safety systems and assets. He / She will understand how current and future components of the information and systems portfolio can be developed to ensure optimal benefit for the user community and the organization.

The role has responsibility for informing and supporting the technical evolution of the GPS systems estate throughout its lifecycle ensuring it addresses changing external requirements and business goals (i.e. regulatory obligations technological advancements core business processes and information standards). The role holder will also lead the capture and development of user requirements and protect AZs License to Operate (LtO) by ensuring that all change is conducted in line with applicable standards (e.g. GxP requirements systems validation privacy and security etc).

The role has responsibility for informing and supporting the technical evolution of the PV systems estate. More specifically this role will have the responsibility to support business by providing information by means of reporting from the PV systems estate ensuring that it addresses the changing external requirements and business goals throughout its lifecycle (i.e. regulatory obligations technological advancements core business processes and information standards). The role holder will also lead the capture and development of user requirements and protect AZs License to Operate (LtO) by ensuring that all reporting requirements and associated changes are conducted in line with applicable standards (e.g. GxP requirements systems and reporting validation privacy and security etc).

Accountabilities

• Serves as a Subject Matter Expert (SME) within the PS Technical Solutions Team for reporting systems ensuring they are capable of delivering high quality expertise and services across the PV systems estate ensuring prioritized requirements and the strategic goals of stakeholders are understood and supported.

• Manages applicable tools documentation and methodologies to ensure the reporting needs of organization are fully addressed and supported.

• Responsibilities of PV systems inclusive of relevant system processes ensuring that the:

• System is changed in an effective and timely manner to meet new health authority requirements and / or changed business demands (e.g. divestment inlicensing partnership etc.).
• Technical components of the system are upgraded in a compliant and riskminimized manner.
• Lead and coordinate routine system maintenance activities (e.g. MedDRA WHODD Ontology updates)
• System enhancement requests are identified and prioritized (change control and major change projects).
• Access to data is controlled training requirements are defined and use of the system is compliant with all applicable regulations.
• User support arrangements (e.g. training helpdesk) and Service Level Agreements are in place irrespective of whether delivered internally or by external vendors / providers.

• Supports the ongoing business utilization of PS systems including troubleshooting problems and developing solutions.

• Provides technical input and guidance on the development of strategic plans for PS systems across the enterprise.

• Evaluates new modules and software upgrades and assesses the impact on system validation the user community and PV processes.

• Retains a global perspective around the business need for accurate highquality effective and efficient information while maintaining a focus on regulatory and corporate compliance needs.

• Anticipates business regulatory and wider industry trends and apply these in the evolution and development of safety solutions.

• Accountable for ensuring the quality of businessrelated content of relevant improvement project proposals and associated documentation in line with Company goveranance process requirements.

• Contributes to the development of procedures work instructions system specifications related to the use GPS information sources and toolsets.

• Participates in interactions with interal and external partners and health authorities on electronic safety data exchange.

• Supports the GPS as required in the license partner/CRO pharmacovigilance agreement (PVA) process.

Essential Skills/Experience

• Bachelors degree in a scientific discipline with relevant experience in supporting safetyrelated activities in clinical biopharmaceutical development.

• Significant experience (10 years) in pharmacovigilance with a proven record of supporting safety tools/solutions.

• Proven competence in designing delivering deploying or maintaining information/systems solutions in support of safety.

• Broad knowledge of safety information tools required to support drug development and marketed brands within AstraZeneca.

• Ability to articulate complex safetyrelated business needs in the context of IS systems design architecture and development.

• Significant experience in system validation audit and PV inspection activities and requirements.

• Excellent interpersonal and communication skills with the ability to efficiently communicate with all levels of the organization.

Desirable Skills/Experience

• Higher degree in a clinical or safetyrelated discipline.

• Awareness of broader technological developments leveraged to inform the design and development of AZ PV Systems.

• Ability to identify opportunities for continuous improvement based on strong awareness of external competitive practice.

• Ability to lead diverse teams across multiple geographies to deliver on objectives.

• Experience across multiple therapeutic or business areas or in safetyrelated roles within other biopharmaceutical regulatory or health organizations.

• Knowledge of procedures governing clinical trial data with health authorities worldwide and experience implementing these within the business.

• Experience working across different geographic locations organizations and cultures.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca is dedicated to pioneering new science and breaking boundaries with our innovative pipeline. Our focus on evaluating novelty and clinical development has led us to achieve top rankings in invention scales. With an ambitious goal to deliver six new molecular entities by 2025 we continue to push forward with bold innovations and integrated healthcare systems. Our collaborative research environment unites academia and industry to expedite research in some of the hardesttotreat cancers. Join us to build a rewarding career as part of a team committed to improving millions of lives.

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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.