Are you ready to lead and innovate in the field of pharmacovigilance? As the Senior Director of Risk Management (REMS) at AstraZeneca, you will leverage your expert knowledge of pharmacovigilance processes, including Risk Management and REMS, to make a significant impact. You will work closely with the Risk Management Group and US Marketing personnel, taking charge of REMS strategy, design, evaluation, and implementation. Your role will involve planning, executing, and overseeing all activities related to REMS programs for AstraZeneca/Alexion products. This includes managing REMS vendors, developing KPIs and compliance metrics, authoring and implementing REMS processes, and ensuring all deliverables are met. You will lead the REMS core team and participate in leadership meetings, driving the success of our REMS programs.
Accountabilities
- Ensure compliance with applicable regulations and AZ Global and Local Policies.
- Collaborate with functions in R&D Marketing Companies (MC), Regulatory Affairs, Medical Affairs, and AZ Legal for process-related activities.
- Collaborate with other members of PS CoE to share best practices, ensure consistency and compliance.
- Lead REMS strategy, design, and evaluation plans in collaboration with Risk Management Director/Senior Risk Management Director and associated US business stakeholders and Global Product teams.
- Lead REMS implementation and evaluation plans including chairing REMS implementation meetings/teams.
- Oversee all activities of REMS vendors, REMS contractors, and/or internal stakeholders who perform REMS activities including contract negotiation, budget, and purchase orders.
- Ensure timely execution of operational aspects of REMS and related activities.
- Author and/or review REMS related documentation, including FDA requests, and approve vendor-authored documents as required.
- Author and implement all REMS related procedures, processes, and associated templates.
- Monitor external environment for regulatory changes impacting REMS and risk management and oversee updates of internal processes and procedures to align with regulatory requirements.
- Own REMS compliance plan and associated processes.
- Ensure audit preparedness and support regulatory inspections for REMS.
- Identify and lead REMS process improvement and compliance-driven activities.
- Partner with internal cross-functional teams to ensure REMS implementation.
- Establish training strategy for REMS-related procedures and deliver in collaboration with US training departments.
- Support program teams and any vendors maintaining effective business relationships and tracking performance metrics including regulatory compliance.
- Lead the development and implementation of internal CAPA plans or oversee the development, implementation, and execution of any necessary CAPA plans for REMS.
- Identify any risks and issues within the REMS processes/systems and propose solutions to mitigate them.
- As the REMS process owner and subject matter expert, lead the development of REMS procedural documents such as SOPs and Working Practice Documents in collaboration with internal/external stakeholders.
- Participate in/support activities for GVP, GCP, GRP, and GMP audits/inspections related to REMS as required.
- Identify opportunities and drive the development/enhancement of standards, techniques, and technology in collaboration with internal/external stakeholders to improve the quality and efficiency of REMs activities.
- Actively contribute to the development of short-term objectives and the long-term vision of the RM group.
- Maintain an awareness of current, new, and changing legislation relating to REMS and understand/implement the impact of changes as required.
Essential Skills/Experience
- A bachelor's degree in science/pharmacy/nursing degree
- 5 pharmaceutical industry experience with at least 3 years experience in patient safety/pharmacovigilance
- Expert knowledge and proven track record of REMS operations
- Expert Knowledge and understanding of relevant FDA requirements and an ability to interpret these standards to achieve business goals
- Experience in design, development, implementation, maintenance, continuous improvement, and ongoing customer support for business processes
- Experience in development and provision of training through virtual meetings and other media
- Excellent project management skills
- Excellent communication and presentation skills
- Experience in audits/inspection activities as related to REMS and/or pharmacovigilance
- Able to work with a degree of autonomy
- Able to represent AstraZeneca externally where required
- Ability to rapidly comprehend the AZ organization and agility in maneuvering across the organization
- Excellent strategic thinking capability
- Excellent understanding of key commercial activities related to REMS
- Detailed Knowledge of REMS guidance and landscape
- Experience of authoring standards documents (Standard Operating Procedures)
- REMS Vendor management experience
Desirable Skills/Experience
- Global Patient Safety experience (beyond US)
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 a passion for science that leads us to pioneer new frontiers. Our team is dedicated to Oncology with a vision to eliminate cancer as a cause of death. With cutting-edge science fused with the latest technology, we aim to deliver breakthroughs that make a real difference. Our collaborative research environment unites academia and industry to expedite research in some of the hardest-to-treat cancers. Join us to build a rewarding career while improving millions of lives.
Ready to take on this exciting challenge? Apply now!
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.
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