US Patient Safety Surveillance Team Leader
The Patient Safety Team Leader (TL) 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. The TL reports to the Director, Patient Safety. Under the leadship of the Director as well as US Patient Safety (PS) Physician in assigned therapeutic areas, the TL is responsible for PSS activities within the US Marketing Company (MC) including the following 4 Major US PSS Activity Categories: (1) safety surviellance support to US MC sponsored clinical studies, (2) Post marketing safety surveillance – focusing on US, while contributing to Global, (3) safety scientific support to US Medical and US Business, focusing on US products’ benefit risk assessment, management, mitigation, and communication, and (4) as assigned or delegated, representation of US PSS at highly selective relevant meetings and committees, e.g., CMT, Pre-SIRC, SIRC. Further details of the US PSS activities are described in the ‘Principal Responsibilities’ section below.
The TL is also involved in cross-functional collaboration efforts of US PSS with Global and US PS functions, Medical Affairs functions, Regulatory Affairs functions, R&D functions, and the Legal department.
The TL does not have any direct reports, however, as a senior level member of the team, the Team Leader has a responsibility to mentor Product Managers and may lead assigned PSS activities in cross functional teams. The TL will collaborate closely with US PS Physicians and Product Managers on a daily basis in order to support the safety surveillance activities.
- Assist the US PS Physician to provide safety surveillance support for US MC sponsored clinical studies (CT, NIS, HEOR, PASS, registry, Pharmacoepidemiology, etc), including:
- providing safety strategy to study teams
- assisting with protocol and study related safety document review and development
- ensuring appropriate safety data collection, review, assessment and implementation of reporting procedures
- supporting clinical studies in safety monitoring, signal detection, safety assessment and risk management
- Provide safety support for Global sponsored US clinical studies and related projects when delegated by Global PS Assist US PS Physician to provide safety support for US managed externally sponsored research (ESR), e.g.,IISR, including:
- participation in ESR local review and provide safety surveillance input to the review process
- review ESR study proposal and protocol and ensure they meet AZ safety handling standards as well as US safety regulations and guidance
- management of safety issues from US local ESR
- Accountable for US specific post marketing safety signal detection, review, management, and documentation Support US PS physician to conduct enhanced follow-up for US AE reports
- Lead the safety scientific support to US safety issue management, response to FDA’s safety inquires, and Global RMP development by providing US perspective and US specific safety information Support US PS physician to provide safety surveillance support for US REMS
- Accountable to develop US specific periodic safety reporting, including production of PADERs and provide US contributions to PBRERs, DSURs, etc.
- Assist the Sr. Product Manager, as needed, in supporting the US PS physician to maintain US labeled list in AZ safety systems Provide US safety information and US perspective to support safety decision making processes including SSaMT, Pre-SIRC, and SIRC Provide US-specific evidence, including involvement with briefing document development for FDA advisory committee meeting or FDA meeting for specific safety concerns
- Under US PS physician’s direction, collobrate with multiple cross functional teams to develop product launch safety surveillance support plan and communicate information to update management and relevant MA functions Assist in risk communication material development
- Assist US PS physician to provide safety support to US safety labeling related activities, including US product promotional materials to ensure consistency with US PI Involvement with support of publications and scientific meetings including
- review of US publications, manuscripts, and abstracts
- participation in safety publication activities
- Participation in cross-functional MA and PS meetings and committees for key products at critical times Mentor Product Manager(s) and Senior Product Manager(s)
- Training in a medical field (ie, physician, pharmacist, nurse) or life sciences graduate, with proven competence in PS and the relevant areas of clinical development
- At least 5 years Patient Safety Surveillance
- An in-depth knowledge of pharmacovigilance practice and an awareness of the latest developments relating to safety surveillance and the potential consequences
- Leadership Capabilities, including: (1) Practice AZ values and behaviors in daily activities (2) Ensure cross functional collaboration (3) Mentor Product Managers (4) Effectively support Director UP PSS and US Physician (5) Actively participate in development of new and refinement of old US PSS processes and standards (6) Lead departmental initiatives
- Mastery of the US PSS activities, including: (1) Commonly be involved in or responsible for challenging products and tasks (2) Mastery of tools, systems and methodology used to conducting daily activities and readily mentor others (3) Be subject matter experts, including PSS processes and procedures (4) Be recognized as a key contributor internally as well as cross-functionally interactive
- Global regulations
- Fully aware of current Global regulations and guidance
- Subject Matter Expert in US patient surveillance
- Involvement in key company-wide process and refinement
- Support Management team for team development and succession planning
- Experience in product risk management and risk minimization
- Experience in clinical research and development, including clinical trials, NIS, HEOR, Pharmacoepidemiologic studies
- Experience in Medical Affairs
- Comprehensive knowledge of Patient Safety Policies, processes, procedures, and specialist areas as these pertain to relevant roles
- Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
- Excellent communication, organizational, and interpersonal skills
- Proven leadership and professional skills
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.