Associate Medical Director, US Patient Safety - Immunology
Associate Medical Director - US Patient Safety, Immunology
Location - Wilmington, DE
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
The role holder promotes the safety of patients who receive AstraZeneca products, with the aim of optimizing overall benefit/risk with a focus on the Immunology Therapeutic Area in the US market.The role holder is accountable to the US Head of Patient Safety Suveillance for patient safety surveillance activities on US Medical Immunology TA sponsored clinical studies, US post-marketing safety evaluations, as well as contributing to Global benefit risk assessment, risk management strategies and related activities.The role holder will also be accountable for deliverables of patient safety support to the US Medical and brand team, including US products’ benefit risk assessment, management, mitigation, training, and communications.The role holder also collaborates with US and Global Patient Safety, Medical Affairs, Regulatory Affairs, R&D, and Legal functions.
What you'll do
- Accountable for US patient safety surveillance activities for Immunology TA.
- Leads cross-functional and multi-skilled safety surveillance team in Immunology TA to ensure delivery of US PS surveillance activities.
- Safety contributions to US MA clinical research activities for the Immunology TA.
- As core member of Risk Evaluation and Mitigation teams to be accountable for providing safety input to US REMS activities.
- Provides US Patient Safety expertise in the development of strategy for FDA regulatory response documents.
- Oversees or provides expert technical support to AstraZeneca clients on a regional and potentially global basis.
- Safety input into US Issues Management.
- Provides US PS input to product global safety governance teams (ie, SSaMTs).
- Contributes to the content of the Safety Sections of the US Prescribing information.
- Represents AstraZeneca and US Patient Safety at external events.
- Networks with colleagues and experts, providing consultancy in own area of expertise and serving as a resource for others by sharing experience within and beyond project team and function.
- Keeps own knowledge of best practices and new relevant developments up to date.
- Litigation safety support.
- Ensures that all work is carried out with regards to AstraZeneca standards and external regulations.
- Closely collaborate with other relevant stakeholders in the global and US business (including regulatory, medical affairs, Real World Evidence, legal).
- Ensures efficient and effective leadership and management of project information, strategy, quality standards, and integrity of information interpretation.
- MD or equivalent degree from US or reputable foreign medical university
- At least 2 years of clinical experience post-registration/certification
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals
- Two or more years of pharmacovigilance and/or drug development experience obtained while working in the pharmaceutical industry or academia
- Extensive general medical knowledge
- Postgraduate training with board certification or equivalent
- Extensive safety experience in a pharmaceutical industry
- Working knowledge of epidemiology
- Working experience of vaccine development and / or immunization
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.