PV Specialist/PV Principal

Hays Specialist Recruitment is now looking for a PV Specialist to work with the Processes and Partnership (P&P) leads in PV Processes, Partnerships and Contracts in Patient Safety Centre of Excellence for a contract assignment at AstraZeneca in Gothenburg.

Working with the Processes and Partnership (P&P) leads in PV Processes, Partnerships and Contracts group in Patient Safety Centre of Excellence, CMO taking responsibility for the management of assigned AstraZeneca projects, processes and partnerships including implementation, communication, compliance, performance and inspection readiness. Accountable to develop relationships across Patient Safety and Centre of Excellence in CMO and other relevant areas of AZ to execute the delivery of the processes and partnership strategy, priorities, alongside governance and management of the current procedural documents and partnerships.


Responsibilities
• Identify opportunities for and drives the enhancement of existing processes and partnerships through knowledge of internal and external environment.
•Working with the PV P, P&C leads, and 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
•Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance support to safety and regulatory teams and submissions.
•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.
•Develop and maintain a vision and strategy for nominated pharmacovigilance or regulatory processes.
•Coordination and ownership of the lifecycle management of nominated processes and partnerships, enabling business continuity and compliance.
•Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
•Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes and partnerships.
•Lead the development and/or enhancement of standards or techniques in order to improve the quality, compliance and efficiency of deliverables for the overall group.
•Develop and improve 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
•Participate and /or support 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
•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.
•Seek personal and professional development opportunities, and share knowledge gained in open forums
•May represent AZ on industry bodies
•Serve as the delegate, where appropriate, for the PV P, P &C Leads
•Contribute to communication and change management activities associated with processes and partnering initiatives.
•Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships
•Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships
•Participate in development and implementation of strategic outsourcing activities

Education, Qualifications, Skills and Experience


Essential:
• A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
• Experience in working cross-functionally
• Leadership skills, including proven leadership of project teams experience
• Thorough scientific knowledge sufficient 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
• Relationship builder
• Able to work effectively as a member of a cross-functional or global team
• Able to work with high degree of autonomy
• Understanding of change management process
• Maintains high ethical standards
• Good time management
• Fluent in English
• Computer literate


Desirable:
• MSC/PhD in scientific discipline
• Knowledge of new and developing regulatory and pharmacovigilance expectations
• Knowledge of existing AstraZeneca external alliances and collaborative projects
• Knowledge of CoE and CMO operating model
• Experience of working with third party suppliers.
• Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry