US Patient Safety Product Manager
The BioPharmaceuticals Business Unit (BBU) creates and executes meaningful therapeutic area and product strategies that are focused on addressing the unmet needs of patients around the world. We are committed to changing the course of medicine and bringing innovative therapies to enhance the quality of life for our patients. The BBU integrates commercial, market access, medical, digital, and corporate functions to drive scientific development and commercial excellence in the core areas of respiratory, cardiovascular, renal and diabetes disease.
The Patient Safety Surveillance Product Manager will promote the safety of patients who receive AstraZeneca products, with the aim of optimizing overall benefit/risk with a focus on the US market. This position reports to the Director, Patient Safety. Under the leadership of the Director, US Patient Safety Physician and Patient Safety Team Leader in assigned therapeutic areas, you will be responsible for PSS activities within the US Marketing Company including the following 3 Major US PSS Activity Categories:
- Safety surveillance support to activities related to US Marketing Company sponsored clinical studies.
- Post marketing safety surveillance – focusing on US.
- Safety scientific support to assigned activities related to US Medical and US Business. If required, the role holder may take on Global Patient Safety responsibilities or collaborate with Global Patient Safety on Global projects.
The Product Manager does not have any direct reports but will collaborate closely with the Team Leaders daily in order to support the safety surveillance activities. Collaboration with the Patient Safety Team Leaders includes providing safety surveillance support for activities related to US MC sponsored clinical studies (CT, NIS, HEOR, PASS, registry, Pharmacoepidemiology, etc), safety support for Global sponsored US clinical studies and related projects when delegated by Global PS, and assist US PS Physician to provide safety support for US managed externally sponsored research (ESR), e.g., IISR.
- Responsible for US specific post marketing safety signal detection, review, management, and documentation.
- Assist the Patient Safety Team Leader by providing data support to Team Leader in preparation for US safety issue management, response to FDA’s safety inquires, and Global RMP development by providing US perspective and US specific safety information.
- Assist the Patient Safety Team Leader by providing data support for US specific periodic safety reporting, including production of PADERs.
- Assist in risk communication material development by providing data support to the Patient Safety Team Leader and US Physician.
- Training in a medical field (i.e., physician, pharmacist, nurse) or life sciences graduate, with proven competence in Patient Safety and the relevant areas of clinical development.
- At least 3 years Patient Safety experience.
- Ability to acquire and assimilate knowledge in different disease and therapeutic areas.
- Excellent communication, organizational, and interpersonal skills.
- Proven professional skills.
Next Steps – Apply today!
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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.