Associate Director, Patient Safety Technical Solutions

Job Title: Associate Director, Patient Safety Technical Solutions

Global Career Level: E

Introduction to role

Patient Safety Technical Solutions, part of Operations, Technology & Analytics, is accountable for the effective governance, maintenance and enhancement of systems owned by Global Patient Safety and for delivering expert services in support of their use by the business. PV Systems ensure that the company’s pharmacovigilance, regulatory and legal obligations, in respect of the applicable systems, can be fully met. The group’s remit encompasses the following systems:

• Pharmacovigilance Systems

• Safety Surveillance Systems

• Other Safety Systems (e.g. Risk Management Portal)

The majority of these systems support regulated business processes, and are maintained in a validated state against mandatory standards, both internal and external. Of particular importance here are Sapphire/Jasper and Business Objects, the Company’s global safety database and reporting system. These systems are enterprise-wide and business-critical, driven by pharmacovigilance legislation (GVP) and ICH E2B standards.

PV Systems is accountable for ensuring that all the systems it owns are:

• Effectively maintained, developed and supported to meet the needs of the business.

• Administered, accessed, maintained, changed and used in accordance with all regulations pertaining to, or impacting upon, electronic systems, records, data, signatures (e.g. FDA 21 CFR Part 11, GCP, GVP, GMP, etc).

Reporting to the PV Systems Head with primary responsibility for system ownership and business tool management, the PV Systems Business Quality Manager is responsible for ensuring that the systems which PV Systems own are fully compliant with the GxP requirements arising from the regulated business processes which they underpin. The individual provides Quality Management oversight across PS CoE’s computerized systems, ensuring that the full set of validation documents exists, that they are clear, complete and retrievable, and ultimately, that the systems meet the applicable GxP requirements.

Accountabilities

• Responsible for ensuring that GxP regulatory compliance requirements on Global Patient Safety owned computerized systems that support GxP regulated business processes are understood and met.

• Provide Quality Management oversight of computerized systems owned by Global Patient Safety, ensuring GxP requirements are considered, and necessary validation documents are clear, complete, and retrievable.

• Offer Quality Management expertise for Global Patient Safety owned systems to ensure they meet all relevant GxP requirements and quality standards.

• Maintain an overview of the Global Patient Safety system estate from a QM perspective and a high-level view of system changes.

• Approve the Regulatory Impact Determination (RID) for all PS CoE-owned systems and provide expertise in generating the RID to determine GxP impact and validation needs.

• Review and approve User Requirements Specification for all PS CoE-owned systems, ensuring GxP-related requirements are included and clearly identified.

• Provide input to the high-level risk assessment process to ensure GxP impact risks are managed.

• Review and approve the Validation Plan for all Global Patient Safety owned systems, ensuring planned activities address GxP requirements. Approve User Acceptance testing.

• Sign off all Global Patient Safety owned systems into use via approval of the Validation Report, providing evidence to support compliance status.

• Participate in project audits, quality management reviews, and inspections as necessary, providing an independent quality voice.

• Contribute to the overall quality of PS CoE-owned systems by collaborating with business and R&D IT teams responsible for system maintenance and upgrades.

• Ensure overall system quality through early deviation detection and risk reduction.

• Maintain up-to-date knowledge of internal and external regulations pertaining to computer system validation with an emphasis on GxP processes, recommending changes as necessary.

• Work closely with the R&D IT Quality Manager and Business Project Manager on each project to ensure understanding of potential GxP impacts.

Essential Skills/Experience

• Bachelor’s degree or equivalent experience within the pharmaceutical or IT industries.

• Significant Experience (10+ years) of computer system validation in a regulated environment, preferably the pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc., and knowledge of regulatory (GxP, SOX etc.) requirements for computerized systems and infrastructure.

• Good understanding of current system development lifecycle methodologies.

• Proven skills in formulating an independent and objective recommendation.

• Experience of how to determine, reach and maintain acceptable quality levels.

• Experience of performing, reviewing and approving risk assessments.

• Clear evidence of organizational skills.

Desirable Skills/Experience

• Ability to proactively identify potential compliance issues and subsequently advise on their avoidance/resolution/remediation.

• In-depth knowledge of current developments in the pharmaceutical industry and global regulatory environment, and their potential impact on regulatory compliance, pharmacovigilance, signal and risk management activities, safety value demonstration, and safety science-related activities.

• Experience of delivering enhancement projects for a GxP, ER/ES, GVP or other ‘regulated’ system.

• Key capability requirements:

• Understanding and management of risk

• Building relationships across cultures, functions, and disciplines

• Keen analytic and problem-solving skills

• Strong focus on quality

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Unleash your imagination. Follow the science, be curious and explore! One of our core values is: Follow the science. This guides our decision-making at every level. It means that our teams are backed to push the boundaries of science. With no limits to our curiosity, we continuously question and explore. We make bold moves at the cutting edge, transforming molecules to change the practice of medicine. Since our renewed focus on building our Oncology function, we have had great successes with 7 new Oncology medicines since 2013. We set the tone for the rest of the industry by consistently publishing our findings in high-impact journals and leading with expertise and entrepreneurial spirit. And we continue to push forward; in 2019 we invested $6.1bn in Research & Development.

Join us today to make a meaningful impact!

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 authorisation and employment eligibility verification requirements.