Job Title: Associate Director, Patient Safety License Agreements & Contracts

Career Level -E

Introduction to role

Are you ready to make a significant impact in the world of patient safety? 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.

Accountabilities

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 AstraZeneca’s 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.

Essential Skills/Experience

A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety, and partnership)

Experience in working cross-functionally

Leadership skills, including proven leadership of project teams experience

Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues

Thorough knowledge of the drug development process

Good attention to detail

Excellent written and verbal communication skills

Proven track record to work across cultures

Knowledge of AZ Business and processes

Able to influence whilst maintaining independent and objective view

Strong collaboration skills

Strong negotiation, conflict management, and interpersonal skills

Relationship builder

Able to work with a high degree of autonomy

Able to work effectively as a member of a cross-functional or global team

Understanding of organisational change process

Maintains high ethical standards, including a commitment to AstraZeneca values and behaviours

Good time management

Fluent in English

Computer literate

Desirable Skills/Experience

MSC/PhD in scientific subject area

Knowledge of new and developing regulatory and pharmacovigilance expectations

Knowledge of existing AstraZeneca external alliances and collaborative projects

Knowledge of GRAPSQA operating model

Experience working with third-party suppliers

Experience working in a global organization, preferably within the pharmaceuticals industry, with an understanding of the drug development life cycle and commercial aspects

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.

At AstraZeneca, we are driven by our passion for science. We are committed to making a difference by fusing data and technology with scientific innovations to achieve breakthroughs. Our inclusive environment encourages collaboration with academia, biotechs, and industry leaders. We offer opportunities for lifelong learning, career development, and making a meaningful impact on patients' lives worldwide.

Ready to take on this exciting challenge? Apply now!

Date Posted

29-Jan-2025

Closing Date

14-Feb-2025

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 authorization and employment eligibility verification requirements.