Director Patient Safety Cluster Lead UKIM

Location: London UK (3 days per week on site)

About AstraZeneca

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialisation of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies. At AstraZeneca we are pioneering new frontiers by identifying and treating patients earlier working towards the aim of eliminating cancer as a cause of death.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

Join AstraZeneca as Director Patient Safety Cluster Lead (UK Ireland and Malta) and steer pharmacovigilance across a multi-country cluster. You will set strategic direction lead day-to-day operations and build a high-performing team to deliver all PS activities in full compliance with local regulations global requirements and GVPupholding the highest ethical standards. Youll be responsible for end-to-end PS processes lead complex risks and drive innovative scalable solutions that close gaps and improve ways of working. Success requires clear guidance strong cross-functional collaboration and the ability to influence diverse internal and external stakeholders to deliver measurable impact.

Key Responsibilities:

Patient Safety Management and Regulatory Compliance

• Lead local PS team and/or PS activities at the local country level to ensure compliance with local health authorities regulations & AstraZeneca Requirements.

• Ensure the appointment of appropriately qualified personnel to act as the Local Qualified Person for Pharmacovigilance (LQPPV) and deputy LQPPV

• Ensure full and timely response to any patient safety query from the local regulatory authority related to patient safety function.

• Ensure local processes procedures and systems are in place for collection processing (including follow-up and archiving) and reporting of clinical and post-marketed adverse events from all sources to meet AstraZeneca pharmacovigilance standards and local regulatory requirements.

• Support audit & inspection process & respond to all queries and lead the identified gaps as per GVP.

• Ensuring local PS procedures are established at the local level and in compliance with AstraZeneca and global/local regulatory requirements.

• Maintain oversight of the external vendor engagement and core deliverables to ensure delivery per AZ requirements and external regulatory standards.

• Support management of local safety agreements and update Pharmacovigilance Agreement Listings (PAL)

• Ensure monitoring of different digital activities (websites applications social media pages etc) as per AZ global procedure

• Ensure Quality Issues are collected on AZ systems and CAPAs are closed on time.

• Monitor PS compliance reports and provide guidance and support to the local PS team

Pharmacovigilance and Risk Management Conduct activities interactions and cross-functional collaboration.

• Work with the Patient Safety team to establish strong relationships and effective collaboration between Regulatory Marketing Medical Affairs Clinical and other internal and external stakeholder functions to deliver patient safety requirements for business and regulatory needs.

Team Management and Development

• Accountable for people management and development

• Develop individual and team accountability and ensure team development by updating Individual development plans for each team member and providing support to accomplish the plans.

• Encourage identification of opportunities for operational improvement and coordinate implementation of improvement initiatives including but not limited to policies procedures standards guidance training programs and system improvements.

• Establish and maintain a high-performance culture through the application of performance management processes.

• Monitor and manage resource and budget needs

Pharmacovigilance network and Health Authorities Partnership

• Work on the development of a strategic partnership with local health authorities aligning AstraZeneca patient safety objectives with the overall objectives of the health authority and the needs of the local community.

• Work with local pharmacovigilance industry networks to establish effective collaboration to ensure AstraZenecas voice is heard in discussions about the regulatory needs of our product portfolio in terms of patient safety.

Requirements:

• Life science degree or appropriate professional qualifications

• Extensive experience of pharmacovigilance

• Extensive experience in relationship and stakeholder management

• Demonstrable knowledge of legislation governing pharmacovigilance in the UK and EU.

• Ability to effectively influence and interact with cross-functional colleagues

• Line management experience

Desirables:

• Advanced scientific degree

• Leadership problem-solving influencing and conflict resolution skills.

• Understanding of multiple aspects of Medical Affairs Regulatory Clinical Research and Commercial Operations

• Medical knowledge in AZ Therapeutic Areas

• Medical Marketing experience

• Change management skills and people development skills

• The ability to work in a complex business-critical and high-profile environment building credibility in ambiguous situations.

In Office Requirement:

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Competitive salary and benefits package on offer!

The successful candidate will have access to a flexible employee benefits fund including holiday purchase and flexible time off pension contributions Share Save Plans A performance recognition scheme and a competitive generous remuneration package.

Date Posted

Closing Date