Job Title: Global Patient Safety US PS Operations & Business Support Director
Location: Onsite w flexibility in Wilmington, DE
Job Description / Capsule
This role is responsible for leading the operations and business support group within the US Market. The purpose of this role is to ensure strategic pharmacovigilance support to US commercial, regulatory and marketing teams and the broader enterprise as required. The accountability for this role is driving adverse event case handling and business process excellence.
Required Education, Skills and Experience
- Establish and implement strategies and objectives which align with the Global Patient Safety strategy
- Allocate resources according to business priorities and objectives
- Provide coaching expertise and leadership to the US Operations and Business support team, ensuring that the team is appropriately trained according to internal and external requirements and that the team outputs are high quality and cost effective.
- Develop, implement and monitor strategies to create adherence and mitigate risk across US pharmacovigilance and business support activities
- Ensure compliance with both AZ requirements and global and local regulatory requirements for patient safety; ensure corrective and preventative actions are taken in the event of local non-compliance
- Ensure that an after-hours process is in place, to ensure a customer can report an AE, to respond to regulatory authority questions, to facilitate local health authority unscheduled inspections, and to facilitate the unblinding of local studies if that has been agreed as a local safety responsibility
- Ensures that appropriate cover is in place so that all activities continue to be performed within the required timeframes at all times (including during periods of holiday, unexpected leave etc.)
- Maintains an in depth knowledge of FDA regulations, expectations and regulatory authority contacts
- Ensures that upcoming changes in legislation/guidance are notified to their regional lead for discussion and escalation to relevant stakeholders in Global Patient Safety as required
- Ensures that local regulatory requirements are defined with respect to reporting ICSRs to local Health Authorities, local ethics committees and investigators (including when the clinical distribution hub is used) and ensures that these reports are tracked (tracking conducted by clinical hub when used), so that details of when a report was issued and to whom, are available
- Ensures that the local legal team are informed of threatened, possible or actual legal action
- Ensures a local Business Continuity Process (BCP) for Patient Safety is in place and tested at least annually
- Responsible for supporting a performance-driven culture within Patient Safety in the Region, with visible performance metrics, personal development of staff and visible recognition and rewards
- Able to identify opportunities for/instigate/lead change in the case handling process through innovation, seeking continuous improvement, based on good awareness of external competitive practice
- Provide regular updates of team activities to line manager
- Maintain knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development
AstraZeneca an Employer of Choice
- Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background with proven success in Patient Safety Clinical Development
- A minimum of 5 years of Patient Safety and or Clinical Development Experience
- Thorough knowledge of FDA and ICH regulations relevant to Patient Safety and Adverse Event reporting
- High level of technical competency with an ability to balance against industry standards to achieve business goals
- Able to work with a high degree of autonomy
- Able to work effectively as a member of a cross functional and or global team
- Comprehensive understanding of Patient Safety regulatory obligations
- Proven leadership and professionalism to ensure positive conflict resolutions
- Ability to represent AstraZeneca and Alexion externally when required
- Able to acquire and assimilate knowledge in relevant disciplines, diseases and therapeutics
- Demonstrated professional excellence, achievement and willingness to encourage this in others
- Strong expressive and receptive communication skills in English and across cultures
- Able to influence while maintaining objectivity
- Maintains high ethical standards including a commitment to AZ Values and Behaviors
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse teams 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 offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package! If you have what it takes to create a culture of courageous leadership, creativity and collaboration, please apply today!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.