Assoc. Director; Patient Safety Technical Solutions

Patient Safety Technical Solutions Team

Hays Life Sciences is now looking to recruit 2 Assoc. Director; Patient Safety Technical Solutions to join the Patient Safety Technical Solutions Team for a 1-year contract assignment at AstraZeneca in Gothenburg.

The Patient Safety Technical Solutions Team as a part of the wider Patient Safety Operations, Technology and Analytics Team (OTA) is accountable for managing the information assets and systems owned by the Chief Medical Office (CMO), ensuring they are effectively supported and governed across the enterprise.

Reporting to the 'Associate Director/Director; PS Technical Solutions', the 'Associate Director; Patient Safety Technical Solutions' provides Pharmacovigilance (PV) subject matter and technical expertise across AstraZeneca's enterprise business-critical PV systems. The role holder works within a team of peers, all of whom employ an in-depth 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 enterprise-wide systems that enable PV compliance and reporting. The role holder will work within the Patient Safety 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 specific responsibility for informing and supporting the technical evolution of the PV 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 AZ's 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).

Typical Accountabilities

* Serves as a Subject Matter Expert (SME) across multiple functions within the Patient Safety Technical Solutions Team (Business Objects Reporting, Business Rules Management, Periodic Reports), ensuring it is 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 processes and systems fully address the needs of organization.
* Responsible for maintaining and evolving PV technology inclusive of relevant system processes, ensuring that the:
* Technology is changed in an effective and timely manner to meet new health authority requirements and / or changed business demands (e.g. divestment, in-licensing, partnership etc.).
* Technical components of the system are upgraded in a compliant and risk-minimized 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 technology, including troubleshooting problems and developing solutions.
* Provides technical input and guidance on the development of strategic plans for PS technology across the enterprise.
* Evaluates new modules and software upgrades and assesses the impact on system validation, the user community and PV processes.
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Day-to-Day Duties

* Manages applicable tools, documentation and methodologies to ensure processes and systems fully address the needs of organization.
* Lead and coordinate routine system maintenance activities (e.g. MedDRA, WHODD, Ontology updates)
* Contributes to the development of procedures, work instructions, system specifications related to the use of Patient Safety Technical Solutions owned information sources and toolsets.

Required Skills/ Experience/ Education/ Qualifications

* Bachelor's degree in a scientific discipline
* Significant experience in Pharmacovigilance with proven record of supporting safety tools / solutions.
* Proven competence, with extensive involvement in the successful design, delivery, validation, deployment or maintenance of information/systems solutions in support of safety.
* Experience in working across different geographic locations, organizations, and cultures.

Desirable Skills/ Experience/ Education/ Qualifications

* Excellent interpersonal and communication skills with ability to efficiently communicate with all levels of the organization.
* Knowledge of the procedures, processes and standards governing clinical trial data (documents and data) with health authorities worldwide, and experience of implementing these within the business.
* Higher degree in a clinical or safety-related discipline.

Required/Desired Technical Proficiencies (i.e. Excel, SAP, etc.)

* Microsoft Office Suite
* Business Objects experience (desired)