Typical Accountabilities
- Manage the triage, evaluation, and follow-up of safety documents and clinical or post marketed adverse event information, ensuring accuracy, validity, and compliance with regulations.
- Apply scientific and technical expertise in patient safety, supporting assessments, research, and regulatory reporting, while serving as a knowledge resource and offering statistical consultancy within the department and across teams.
- Lead and mentor the local patient safety team by monitoring performance, hold direct line management responsibility, set individual objectives, conduct performance management, support career development, encourage professional development, assist with succession planning, and delegate of responsibilities and projects.
- Collaborate with external organizations, regulatory authorities, and cross-functional internal teams to ensure the alignment, quality, and integrity of patient safety processes, data, and submissions.
- Develop and support functional, regional, or country-level patient safety strategies, driving continuous improvement initiatives to meet organizational objectives, enhance efficiency, and optimize project outcomes.
- Represent AstraZeneca’s Patient Safety function externally, networks with industry peers, and promote a culture of courageous leadership, collaboration, and continuous improvement.
Qualifications and Skills
Essential: Bachelor’s degree in science or healthcare-related field (or equivalent patient safety experience); advanced degree preferred; extensive experience in patient safety within pharmaceutical, hospital, clinical research, or healthcare settings (including roles as a Specialist within AstraZeneca Patient Safety); thorough knowledge of patient safety processes, local regulations, and international standards (e.g., FDA and ICH regulations for patient safety and adverse event reporting); broad competence with medical, therapeutic, and technical terminology; demonstrated leadership with the ability to motivate, empower, and guide teams to achieve objectives, including cross-functional team leadership; proven ability to manage priorities, resources, performance targets, and project initiatives in global and regional environments; excellent written and verbal communication skills, along with negotiation, collaboration, and interpersonal leadership abilities; proactive in identifying patient safety issues, implementing solutions, and fostering partnerships with internal and external stakeholders; experience in budgetary and resource management planning; willingness to travel domestically and internationally.
Desirable: Advanced degree in scientific discipline; expert-level recognition across industry; extensive insights into emerging technical regulations; plans, coordinates, and achieves team goals effectively; operational expertise in risk planning and contingencies; exemplifies AstraZeneca leadership values and behaviors; broad understanding of disease complexities with awareness of cutting-edge research and thought leadership; leverages technology and systems to optimize tasks within e-enabled frameworks; exhibits strategic influence and maintains organizational positivity; skilled in conceptual, analytical, and strategic problem-solving; adept in conflict resolution with team-oriented approaches; comprehensive knowledge of AstraZeneca protocols and global guidelines; proven project management, time management, and organizational skills; delivers training and mentoring for adverse event reporting and professional development; proactively seeks continuous learning opportunities in pharmaceutical sciences.
Key Relationship to Reach Solutions
Internal: Senior Management within Patient Safety; Compliance Team; Members of Development function.
External: External service providers and regulatory bodies.
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.
