Associate Director, Patient Safety License Agreements& Contracts

As an Associate Director, Patient Safety License Agreements & Contracts at AstraZeneca, you will work closely with the Pharmacovigilance Agreements Lead to negotiate optimal safety agreements and contracts. Your role will be pivotal in establishing excellent collaborations and maintaining positive working relationships with third-party partners, ensuring efficient and low-risk delivery through governance, relationship management, standardization, and alignment.

• Negotiate optimal, compliant Pharmacovigilance (PV) Agreements for AstraZeneca while fostering excellent collaborations and maintaining positive relationships with third-party partners.

• Provide expert advice, guidance, and interpretation on PV Agreements to demonstrate the value of Patient Safety as a key contributor to AstraZeneca's business.

• Collaborate with OTA, GPPS, and Legal teams to ensure optimal and compliant PV obligations in commercial agreements.

• Support MC Safety Managers in creating and managing local PV Agreements.

• Provide support for all LP audits and ensure remediation of findings.

• Coordinate and own the lifecycle management of Licensing Agreements to ensure business continuity and compliance.

• Monitor standards and compliance measures related to PV Agreements to support collaborations and continual improvement.

• Identify opportunities for enhancing existing processes and partnerships through knowledge of internal and external environments.

• Develop, establish, monitor, report, and assess global KPIs related to safety and regulatory data reporting with the Pharmacovigilance Agreements Leads and Patient Safety and Regulatory experts.

• Utilize safety and regulatory knowledge to maintain and support the global inspection readiness strategy.

• Manage relationships / partnerships / alliances essential to delivering AstraZenecas pharmacovigilance and regulatory responsibilities.

• Provide process or compliance support to safety and regulatory teams and submissions using deep understanding of regulatory and pharmacovigilance processes.

• Establish a culture of continuous improvement, high performance, flexibility, and quality with a can do attitude.

• Contribute to the overall management and oversight of the PV Quality System.

• Coordinate and manage new and existing partnerships and agreements.

• Promote innovation and new ways of working to drive efficiency and improved deliverables in all processes and partnerships.

• Lead the development or enhancement of standards or techniques to improve quality, compliance, and efficiency of deliverables.

• Identify issues and risks, proposing options to mitigate them.

• Ensure appropriate, up-to-date records are maintained for compliance.

• Participate in/support activities for GVP, GCP, GRP, and GMP audits/inspections.

• Deliver on project assignments supporting the business, including 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.

• Represent AZ on industry bodies where appropriate.

• Serve as the delegate for the PV Agreements Team Lead when vital.

• Contribute to communication and change management activities associated with processes and partnering initiatives.

• Build relationships with team members and customers to support pharmacovigilance and regulatory activities and responsibilities, including successful partnerships.

• Work collaboratively to provide expertise and share standard processes across all regions and partnerships.

• Participate in the development and implementation of strategic outsourcing activities.