ASSOCIATE DIRECTOR, PATIENT SAFETY LICENSE AGREEMENTS & CONTRACTS

Working with the Director, Pharmacovigilance Agreements Lead, negotiating optimal safety agreements and contracts for AstraZeneca whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners). Through the use of governance, relationship management, standardization and alignment ensure delivery in the most efficient lowest risk manner.

• Negotiate optimal, compliant, Pharmacovigilance (PV) Agreements for AstraZeneca whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners)
• Provide customers with expert advice, guidance and interpretation of matters pertaining to PV Agreements to demonstrate the value of Patient Safety as a key contributor to AstraZeneca internal and external business
• Collaborate with OTA, GPPS and Legal providing advice and support for commercial agreements ensuring that optimal and compliant PV obligations are included as required
• Collaborate with MC Safety Managers, providing advice and support for the creation and management of local PV Agreements
• Provide support to all LP audits as required and ensure remediation of findings.
• Coordination and ownership of the lifecycle management of the Licensing Agreements process enabling business continuity and compliance.
• Monitor standards and measures of compliance in relation to PV Agreements to support collaborations and continual improvement
• Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment.
• Working with the Pharmacovigilance Agreements Leads, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
• Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
• Manages relationships/partnerships/alliances external to the AstraZeneca OTA function that are essential to delivering AstraZeneca’s pharmacovigilance and regulatory LTO responsibilities
• Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance support to safety and regulatory teams and submissions.
• Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
• Contribute to the overall management and oversight of the PV Quality System.
• Coordination and ownership of the management of new and existing partnerships and agreements
• Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes and partnerships.
• Lead the development and/or enhancement of standards or techniques in order to improve the quality, compliance and efficiency of deliverables for the overall group.
• Identify issues and risks and propose options to mitigate them.
• Ensure that appropriate, up-to-date records are maintained for compliance
• Participate and /or support activities for GVP, GCP, GRP and GMP audits/inspections
• Deliver on project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces.
• Provide training to OTA, partners and other functional groups.
• Seek personal and professional development opportunities, and share knowledge gained in open forums
• May represent AZ on industry bodies
• Serve as the delegate, where appropriate, for the PV Agreements Team Lead
• Contribute to communication and change management activities associated with processes and partnering initiatives.
• Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships
• Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships
• Participate in development and implementation of strategic outsourcing activities