Associate Principal Specialist - PV Processes and Partnerships

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives – and are made to feel valued, energized and rewarded for their ideas and creativity.

We are now recruiting an associate principal specialist within pharmacovigilance.

Dina arbetsuppgifter i huvudsak
Yo will be working with the Processes and Partnership (P&P) leads and Principals in PV Processes, Partnerships and Contracts group in Patient Safety Centre of Excellence, CMO having ownership of the management of assigned AstraZeneca projects, processes and partnerships including implementation, communication, maintenance, compliance, continuous improvements, performance and inspection readiness. You will also collaborate with functions in CoE, Patient Safety, R&D Oncology, R&D BioPharmaceuticals, AZ Marketing Companies and AZ Legal providing advice, guidance and interpretation of matters relating to assigned areas to ensure compliance with applicable industry regulations and AstraZeneca Global and Local Policies.
Responsibilities:
• Providing specialist knowledge and support to be recognized as experts and source of reference for PV PP&C, Patient Safety and other stakeholders.
• Identify opportunities for and lead the enhancement of existing standards, processes and techniques through expert knowledge of internal and external environment in order to improve the quality, compliance and efficiency of deliverables for the overall group.
• Accountable for assessing the effectiveness of improvement or CAPA initiatives with identification of subsequent further improvement actions as needed.
• Accountable to demonstrate and contribute to a culture of “ownership”with efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/stakeholder engagement.
• Working with the PV P, P&C leads, Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
• Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
• Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca’s pharmacovigilance and regulatory LTO responsibilities
• Project manage projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross functional teams.
• Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
• Contribute to the overall management and oversight of the Pharmacovigilance Quality System.
• Continously improve the the vision and strategy for nominated pharmacovigilance or regulatory processes.
• Lead improvements of reporting tools and analysis processes and technology.
• Performing the monitoring, analysis and trending of data.
• Identify issues and risks and propose options to mitigate them.
• Monitor, interpret and validate current, new and changing legislation, and manage the impact of changes.
• Ensure that appropriate, up-to-date records are maintained for compliance
• Represent PV PP&C in activities for GVP, GCP, GRP and GMP audits/inspections
• Provide support to the outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintaining inspection readiness
• Deliver on project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces.
• Provide process training to relevant stakeholders in CMO, partners and other functional groups.
• May represent AZ on industry bodies
• Serve as the delegate, where appropriate, for the PV P, P &C Leads
• Lead development and implementation of strategic outsourcing activities for assigned areas

Vem är du?
Essential
• A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
• Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals
• Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role
• Experience in working cross-functionally
• Experience from authoring standards documents (Standard Operating procedures)
• Experience from development and provision of training through virtual meetings and other media
• Leadership skills, including proven leadership of project teams experience
• Expertise to understand all aspects of regulatory/pharmacovigilance and partnership issues
• Thorough knowledge of the drug development process
• Good attention to detail
• Excellent written and verbal communication skills
• Proven ability to work across cultures
• Able to influence whilst maintaining independent and objective view,
• Strong collaboration skills
• Strong negotiation, conflict management and interpersonal skills

Desirable

• Knowledge of AZ Business and processes
• MSC/PhD in scientific discipline
• Excellent knowledge of new and developing regulatory and pharmacovigilance expectations
• Change management experience
• Excellent knowledge of inspections/inspection activities as it relates to Lead Area
• Key capabilities:
o Understanding of governance processes
o Process improvement (eg Lean methodology)
o Collaboration/co-ordination
o Financial awareness
o Ability to influence without authority
o Open to multiple perspectives
o Balanced perspective
o Solution focused
o Experience with inspection activities

Om verksamheten
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 or any other characteristic protected by law.