Provides leadership and direction in area of expertise on pharmacovigilance activities as an expert or through the supervision of the US Patient Safety Compliance Management or Quality & Enablement (Business Support or Safety Systems & Analytics team) section on a variety of pharmacovigilance activities of multifaceted scope and complexity to both mitigate risk to the business and support our license to operate. Recognized as an expert in own field and often first point of contact for related queries. Provides analysis and trending of data and collaborates with stakeholders to identify trends through project management activities. Develops and maintains pharmacovigilance process and technology vision and strategy in support of the US region.


Provides leadership and direction in area of expertise on pharmacovigilance activities as an expert or through the supervision of the US Patient Safety Compliance Management section on a variety of pharmacovigilance activities of multifaceted scope and complexity to both mitigate risk to the business and support our license to operate. Recognized as an expert in own field and often first point of contact for related queries. Provides analysis and trending of data and collaborates with stakeholders to identify trends through project management activities. Develops and maintains pharmacovigilance process and technology vision and strategy in support of the US region.


Typical Accountabilities/Responsibilities


• Ensures and monitors compliance by team members and 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) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.


• Acts as a regional technical expert providing consultative guidance and support to internal groups and project teams for local processes ensuring compliance with global and local procedural documents and local implementation of pharmacovigilance objectives, policies, processes and procedures.


• Serves as a technical knowledge expert with a deep understanding of internal, local and international regulatory requirements, regulations and guidance at the global and Regional level relevant to pharmacovigilance activities.


• Provides guidance to internal groups and project teams based on technical knowledge towards development of strategic and tactical plans.


• Leads and/or contributes to establishing and implementing policies, procedures and objectives for own work or though managing a team, to improve the quality, compliance and efficiency of deliverables for overall team efficiency based on good awareness of external competitive practice and required regulatory requirements.


• Manages a wide range of problems independently, requiring complex judgments and innovative solutions, needing well-developed conceptual thinking and thus having a high level of business risk management.


• Actively leads and provides guidance and support for regulatory inspection and audits.


• Leads pharmacovigilance outsourcing activities through identification, selection, negotiation, and/or management and maintenance of Good Pharmacovigilance Practices (GVP) and required pharmacovigilance activities in assigned projects.


• Reviews adverse event documents prepared by US Patient Safety personnel for accuracy, completeness, and compliance.


• Accountable for specialized research or delivery of internal reports to enhance the effectiveness of pharmacovigilance contributions to local and/or global submissions across a range of products.


• Manages and authors applicable process procedural documents, guidance documents or system specification documents.


• Leads the monitoring of compliance with safety-related regulations, corporate policies, SOP's and guidelines through internal audits, quality control and training.


• Ensures that regional input is provided in determining requirements for new/updated processes and procedures in support of internal, local and international regulatory requirements.


• Collaborates with line management on resource activities to insure appropriate prioritization of resources to deliver key work and provides feedback to ensure the right skills and expertise are deployed to the team to enable achievement of its objectives.


• Implements continuous improvement plans around departmental compliance of local and global guidelines, working instructions, SOPs and Corporate policies.


• Develops innovative strategies to meet US Patient Safety's training needs.


• Provides leadership around project management activities in US Patient Safety.


• Liaises with internal and external stakeholders as necessary for issue and resolution activities.


• Demonstrates the ability to present information to both internal and external stakeholders.


• Conducts training in both classroom and individualized settings.


• Provides support, guidance and training to internal staff.


• Maintains knowledge of the Company disease and therapeutic areas for marketed drugs and drugs in development.


• Supports a performance-driven culture within the teams with visible performance metrics and visible recognition and rewards.


The Patient Safety Team Leader assigned to the Business Support team in addition (as appropriate), also:


• Provides strategic pharmacovigilance support to US Commercial, Regulatory, and Marketing team promotional and advertising campaigns.


• Develops, implements and monitors strategies to create adherence and mitigate and assess risk across US pharmacovigilance business support activities.


• Provides explanation to leadership team regarding departmental US Business Support activities.


The Patient Safety Team Leader assigned to the Compliance Management section, also:


• Provides strategic pharmacovigilance support for local regulatory environment awareness and compliance initiatives.


• Develops, implements and monitors strategies to create adherence and mitigate and assess risk across US compliance, inspection readiness and pharmacovigilance agreement activities.


• Leads or supports regional pharmacovigilance licensing partner agreement activities:


o Assesses licensing partner's pharmacovigilance capabilities and processes.


o Assesses the pharmacovigilance organizational structure of licensing partner to understand how decisions are made and who makes them.


o Liaises as necessary with licensing partners for agreement on compliance questions and issues.


o Identifies, with the assistance of stakeholder departments, areas of agreement requiring modification and manages that change.


o Oversees the design, implementation, and maintenance of a tool (e.g., database) for capture of key status and content facts for all agreements.


o Ensures that conditions of pharmacovigilance agreements are clearly communicated within Patient Safety.


o Ensures that procedures are in place within US Patient Safety to meet the conditions of the agreements.


o Ensures the continuing compliance of US Patient Safety in adherence to these procedures.


• Leads or supports regional pharmacovigilance auditing activities:


o Manages and assists in developing, implementing and maintaining a comprehensive risk-based pharmacovigilance compliant quality auditing program.


o Plans and conducts pharmacovigilance system audits in support of local Pharmacovigilance activities for post marketed products, external partners/vendors and licensing partners to assure compliance with the Code of Federal Regulations, GxP, ICH and AstraZeneca policies and procedures.


o Authors and manages audit reports to stakeholders and management.


o Obtains audit responses from Pharmacovigilance and external partners/vendors and evaluates proposed corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and AstraZeneca policies.


• Provides explanation to leadership team regarding departmental Compliance data, issues, trends, and action taken.


Required


• Qualified to 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.


• Delivery focused.


• Proven leadership and professional skills, able to resolve conflict.


• Strategic thinking.


• Demonstrated ability to work with a high degree of autonomy.


• Demonstrated ability to work effectively as a member of a cross-functional or global team with ability to work across cultures.


• Demonstrated ability to represent the organization externally where required.


• Demonstrated ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas.


• Proven professional excellence - adds value by applying expertise proactively.


• Demonstrated ability to influence whilst maintaining independent and objective views.


• Maintains high ethical standards, including a commitment to AstraZeneca values and behaviors.


• Excellent communication and organizational skills.


• Detail oriented.


• Computer literate.


Desirable


• Advanced degree within field and/or professional certification (project management, Lean Six Sigma, American Society for Quality (ASQ) Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/ Organizational Excellence, or Society of Quality Assurance (SQA) Registered Quality Assurance Professional (Minimum 3 years of PV-related Quality Assurance auditing experience).


• Strong pharmacovigilance experience within the pharmaceutical industry and prior pharmacovigilance case handling or compliance, audit/regulatory inspection or IS/IT experience in a 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.