Job Title - Associate Director Operations, Global Patient Safety, US Region
Job Location - Onsite with flexibility in Wilmington DE
Provides leadership and direction in area of expertise on pharmacovigilance activities as an expert or through the supervision of the Patient Safety Operations section on a variety of pharmacovigilance activities of multidimensional scope and complexity. This role mitigates risk to the business and supports our license to operate. Recognized as a Patient Safety expert and is often first point of contact for queries. Provides analysis and trending of data and collaborates with collaborators to identify trends through project management activities. Develops and maintains pharmacovigilance process and technology vision and strategy in support of the US region.
Education, Skills and Experience Required
- Ensures and monitors compliance of team (including third parties) by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) championing an open culture where employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.
- Acts as a regional technical authority providing consultative advice and support to internal groups and teams for processes ensuring compliance with global and local processes, documents and local implementation of pharmacovigilance objectives, policies, processes and procedures.
- Serves as a technical knowledge authority with a deep understanding of internal, local and international regulatory requirements, regulations and provides guidance at the global and Regional levels relevant to PV activities.
- Leads Patient Safety activities locally/globally for an assigned product and/or project including when appropriate, management and oversight of operations vendors.
- Proven track record of working successfully with cross-functional teams influencing appropriate plans and actions toward greater efficiency and or clarity.
- Furnishes high-quality outputs from the product-related or process team to meet regulatory and AstraZeneca requirements.
- Works with collaborators to identify local needs within the department and develops innovative approaches to meet those needs.
- Ensures that US input is provided in resolving requirements for new/updated processes in support of internal, local and international regulatory requirements.
- Authors applicable process to keep procedural documents, guidance documents or system specification documents current and in compliance.
- Finds opportunities to lead innovative change, toward continuous improvement based on awareness of external effective practices.
- Supports a performance-driven skills within the teams with visible performance metrics and visible recognition and rewards.
- Demonstrates and maintains solid understanding of internal, local and international regulatory requirements, regulations and guidance at the global and Regional level relevant adverse event reporting.
- Maintains knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.
- Assists and may lead development of strategic and tactical plans in areas of expertise.
- Provides support to the PS Line Management team and leads discussions of ongoing projects with leadership team(s).
- Development/Refinement/Training of Operational processes including using innovative approaches to meet Patient Safety's training needs.
- Provides leadership around Project Management activities in the US PS.
- Resource Projection/Allocation: Collaborate with line managers on resource activities to insure appropriate prioritization of resources to deliver key work. Assists the Patient Safety Leadership Team in strategic resource planning to ensure that all obligations are met.
- Actively supports and provides back-up for regulatory inspections and internal audits. May also provide support for local regulatory environment awareness initiatives.
- Implements continuous improvement plans around departmental compliance of local and global guidelines, working instructions, SOPs and Corporate policies.
- Provides clarity to PS leadership team regarding departmental compliance data, issues, trends, and actions taken.
- Liaises with customers as necessary for issue and resolution activities.
Preferred Education, Skills and Experience
- Qualified to Bachelor's degree level in biosciences or an equivalent healthcare or pharmaceutical industry background with proven competence in Patient Safety/Clinical Development.
- 8-10 years of pharmacovigilance and/or Clinical Development experience with a minimum of 5 years of pharmacovigilance department experience to include knowledge of pharmacovigilance practices, including an advanced understanding of FDA and other Health Authority, and ICH regulatory requirements, guidance and obligations.
- Demonstrated leadership, professional skills, ability to resolve disagreements.
- Critical thinking with a focus on results.
- Demonstrated ability to work effectively as a member of a cross-functional or global team with ability to work across cultures and with a high degree of autonomy.
- Demonstrated ability to represent the organization externally where required.
- Basic competence with medical and therapeutic terminology, with detail orientation.
- Maintains high ethics, including commitment to AZ Values and Behaviors.
- Demonstrated ability to influence whilst maintaining independent objective views.
- Excellent expressive and receptive communication skills in the English language and is well versed in MS Office Suite and other appropriate computer applications.
AstraZeneca An Employer of Choice:
- Advanced degree within field and/or professional certification (project management, Lean Six Sigma)
- Strong pharmacovigilance experience within the pharmaceutical industry and prior pharmacovigilance case handling/compliance in Patient Safety department.
- Strong project management expertise.
- Proven courageous leadership consistently challenging the status quo and promoting motivation and empowerment of others to accomplish individual, team and organizational objectives.
- Professional excellence: Background of high professional achievement and willingness to encourage this in others.
- Creative and Innovative: Seeks to improve continuously where it counts, based on good awareness of external competitive practice, and creativity and initiative.
- Demonstrated ability to develop others, identifying and providing opportunities to improve the capabilities of other people.
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment.
AstraZeneca embraces diversity and equality of opportunity. We're 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 offer a bold Total Reward program including a market driven base salary, bonus and long term incentive grants, annually. We also provide a generous paid time off program and a comprehensive benefits package. If you are ready to create a culture of courageous leadership, and collaboration we would love for you to 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 parental 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.
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