Director, Patient Safety Processes & Partnerships

Location: Barcelona, Spain (On-site): 3 days working from the office.

Major Responsibilities and Accountabilities:

• Owns and is accountable for the long term stewardship of the Pharmacovigilance Agreements business area, ensuring negotiation of optimal, compliant PVAs for AZ whilst establishing good collaborations and maintaining positive working relationships with third party partners.
• Provide advice, guidance and interpretation of matters relating to PVAs to demonstrate the value of Global Patient
• Safety as a key contributor to AZ internal and external business
• Collaborate with R&D Oncology, R&D BioPharmaceuticals, R&D Rare Diseases, Business Operations and AZ Legalproviding advice and support for commercial agreements ensuring that optimal and compliant PV obligations are included as required.

Typical Accountabilities

• Provide guidance to the PVA principals in their authoring and life cycle mnagement of PVAs.
• Accountable for the oversight, lifecycle management and strategic planning and development of the PVA area, ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.
• Partner with relevant counterparts to optimize and deliver effective PVAs.
• Accountable to demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/stakeholder engagement.
• Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement of processes, technology and services within the PVA area they lead.
• Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area.
• Accountable for managing the relationships with partners.
• Partner with Patient Safety Technical Solution counterparts to ensure an integrated and holistic approach to PVA processes and systems.
• Work with the Senior Director, Partnerships & Contract and Senior Director, Inspection Readiness Business. Performance to monitor the overall performance of the processes and technology within the nominated area.
• Track and monitor agreed key performance indicators, oversee the delivery of Corrective and Preventive Actions to time and quality, and act on data or trends identified through the Quality & Risk Management process
• Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance
• Project manage projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross functional teams.

Education, Qualifications, Skills and Experience

Essential

• University degree or equivalent qualification in relevant scientific discipline
• Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals
• Experience from authoring, negotiating and maintenance of agreements and contracts with external party
• · Experience from tracking and monitoring business performance through SLAs and KPis
• Experience of leadership of team, either as line manager or project leader
• Experience in outsourcing and partnership with external vendors
• Ability to manage multiple stakeholders
• Demonstrated excellent skills in: written and verbal communication
• Able to work with high degree of autonomy
• Able to represent AstraZeneca externally where required

Desirable

• 3-5 years Alliance management, and 5-7 years Global Regulatory, Patient Safety and/or Clinical Development experience
• Excellent knowledge of Regulatory Environment (e.g. FDA, MHRA, EMEA, other key markets/areas)
• Change management experience
• Experience with contracts including licensing agreements, safety agreements, etc..
• Excellent knowledge of inspections/inspection activities as it relates to licensing agreements
• Key capabilities: o Understanding of governance processes o Process improvement (eg Lean methodology) o Collaboration/co-ordination o Financial awareness o Ability to influence without authority o Open to multiple perspectives o Balanced perspective o Solution focused o Experience with inspection activities

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.