Pharmacovigilance Lead – Periodic Reports

You will lead their nominated area within PV Processes, Partnerships and Contracts Team within PS Center of excellence within Chief Medical Office. PV nominated Areas Include: Case Handling, Periodic Reports, Signal Mangement, and Medical Device. Responsiilities include: Design, development, implementation, maintenance, continuous improvement and ongoing customer support for the processes, technology, partnerships and services within the area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.


TYPICAL ACCOUNTABILITIES

• Accountable for the oversight, lifecycle management and strategic planning and development of nominated area and the Safety/Regulatory owned processes, procedural documents and partnerships of their nominated area and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies.
• Owns and is accountable for the long term stewardship of their nominated area and for successful delivery of the business benefits.
• Accountable to demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/stakeholder engagement.
• Engage and influence internal and external key stakeholders to drive the strategy, development and continuous improvement of processes, technology and services within the Safety/Regulatory area they lead.
• Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed.
• Ensures that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant stakeholders to improve processes.
• Accountable for managing the relationships with supplier(s) providing all external services to the group as appropriate.
• Partner with system counterparts to ensure an integrated and holistic approach to processes and systems.
• Act as the primary point of escalation for personnel for any risks and issues identified within the assigned area.
• Work with the Section Director, Compliance and Inspection Readiness to monitor the overall performance of the processes and technology within the nominated area. Track and monitor agreed key performance indicators, oversee the delivery of Corrective and Preventive Actions to time and quality, and act on data or trends identified through the Quality & Risk Management process
• Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers
• Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance
• Project manage projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross functional teams.
• In partnership with peers (Other Nominated Area Leads) establish, foster and facilitate a top tier partnership relationship with the outsource provider. Includes championing relationship with internal AZ stakeholders and forging strong partnership with all customers/stakeholders. Ensures that all internal and external relationships and interfaces are managed effectively.

 

EDUCATION, QUALIFICATIONS, SKILLS AND EXPERIENCE

Essential
• University degree or equivalent qualification in relevant scientific discipline
• Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals especially related to periodic reporting
• Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role.
• Experience from authoring standards documents (Standard Operating procedures)
• Experience from development and provision of training through virtual meetings and other media
• Experience of leadership of team, either as line manager or project leader
• Experience in outsourcing and partnership with external vendors
• Ability to manage multiple stakeholders
• Extensive knowledge in project management skills, specifically leading teams
• Demonstrated excellent skills in: written and verbal communication
• Able to work with high degree of autonomy
• Able to represent AstraZeneca externally where required

Desirable

• PhD in scientific discipline
• Knowledge of new and developing regulatory and pharmacovigilance expectations
• Technology Implementation experience
• 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

 

ABOUT ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams! As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.

We believe in growing together!