At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking.
Our Patient Safety team sits within the Chief Medical Office; an integrated, enterprise-wide organisation dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining health authority approvals around the world.
The Executive Director, Global Patient Safety, Operations, Technology and Analytics leads and is ultimately accountable to AstraZeneca for the quality, continuous improvement of processes, relationships, analytics, capabilities and technology supporting Patient Safety.
This is a fantastic opportunity for Patient Safety/Pharmacovigilance professional with strong leadership, collaborative stakeholder management, operational and strategic experience to lead and shape the future strategy of the Patient Safety group moving forwards.
Typical Accountabilities, what you will be doing:
- Process maintenance and governance: Accountable for the oversight, lifecycle management and strategic planning and development of Pharmacovigilance (PV) owned processes and procedural documents, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.
- PV Contracts governance. Establishes, leads, and provides strategic direction to the PV agreements team such that it is capable of delivering a high quality service to customers, both within CMO and across the wider enterprise, that meet or exceed agreed goals/objectives.
- PV contracts Strategy. You will lead the strategy and support business development efforts ensuring PS representation . reimagining the future, leveraging an in-depth understanding of business priorities, external regulatory and pharma industry trends and leveraging new disruptive technologies. Bringing strategic insight and innovative ideas that shape the evolving PV services across the business
- PV Analytics. Accountable for leading analytic data strategies including use of external databases and creation of internal data strategies and standards. Leverage innovative technologies to support scientific exploration
- PV Technical solutions. Establishes, leads and maintains technology environment used by Global Patient Safety. Continuously looks for innovative technology solutions
- PV Learning and Development. You'll have accountability for the development and implementation of a capability build framework for Global Patient Safety.
- Outsourced services. You will have responsibility for outsourced services, robust governance and close collaboration with PV partners. Ensuring creative partnering to continually drive customer-focused deliverables and information-based culture, ensuring quality and efficiency in the management of PV submissions
- Shapes the future. Lead, develop and implement PV process, contracts, technology, analytics and business strategy to achieve and sustain a leading industry position. Innovation and implementation and drive an information based culture.
- Develops effective enterprise-wide transformational change strategies in collaboration with corporate IT functions that will help shape the organization's future.
- Challenge the status quo. Demonstrating innovation and entrepreneurship. Ensuring that internal (e.g. AZ and its partners), external (e.g. industry and Regulatory Authorities), drivers and trends are anticipated & incorporated into evolving PV strategic roadmap
- Anticipates and Addresses Future Capability needs. Deliver effective performance and talent management, recruitment and retention, project resourcing, budget control and overall visible leadership across section. Ensuring teams stay in tune with evolving technologies and health authority regulations. Setting clear objectives and tracking performance
- Generates Step Change in performance of large teams. Lead a diverse and flexible capability that includes both in-house resources and outsourced/off-shored extended capabilities, with footprints in the US, Europe and Far East.
- Creates new opportunities for AZ collaboration. Be a strong advocate for PV Processes, Partnerships and Contracts by building effective relationships within the team and key customers and partners.
Essential Education, Qualifications, Skills and Experience:
- Life sciences professional or information sciences graduate; or equivalent experience in the pharmaceutical industry.
- Previous significant experience of Patient Safety/Pharmacovigilance in the Pharmaceutical industry, with significant experience leading large international teams
- Proven strategic thinking and judgement, setting vision and clear expectations with customers, demonstrating and applying broad business acumen into decision making
- Proven people and change management experience
- Strong links with senior levels of staff in R&D, local operating companies and other enterprise stakeholders
- Good understanding of regulatory guidelines and trends, including GCP and GXP
- Proven experience in developing and implementing new systems and processes
- Understanding current, as well as being visionary in, systems & technology utilized for regulatory information
- Experience of representing a Pharma company externally in relevant areas (e.g. with industry associations or with regulatory authorities)
- Business acumen, with a sound understanding of portfolio governance, program management and investment approaches
- Able to manage and measure budget and productivity efficiency
- Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
- Demonstrated development of others, identifying and providing opportunities to improve the capabilities of other people
Location: Gaithersburg, Waltham US, Cambridge UK or Gothenburg Sweden
Salary: Competitive + Excellent Benefits
Closing Date: 25th August 2022
Next steps, if the role looks suitable please apply!
Where can I find out more?
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