Associate Director, Patient Safety

Key Responsibilities:

• Act as deputy national contact person (NCP) for pharmacovigilance UK.

• Maintaining an in-depth knowledge of the local health authority regulations and updating regional lead, Cluster lead and local teams with anynew changesin legislation/guidance for discussion and escalation to relevant stakeholders in global Patient Safety asrequired.

• Maintainlocal procedural documents associated with patient safety activities are up to date.

• Ensure local information relating to pharmacovigilance activities is reflected accurately in the Pharmacovigilance System Master File (PSMF)

• Maintain oversight of all safety-related processes, issues, and brand activities within their country, including product risk management plans and associated activities.

• Maintain up-to-date knowledge of the marketed status of products in the local country and reference documents (such as Product Information/ core data sheet) in addition tomaintainingup-to-date knowledge related to the global PS procedures/ Guidance.

• Lead Health Authority interactions and queries, such as for ICSR-related products, related safety concerns, and educational materials associated with the Risk Management Plan (RMP).

• Fully trained on different global PS systems .

• Support local safety management agreements and clinical study protocols to fulfil AstraZeneca and local regulatory safety reporting requirements.

• Support external patient safety service providers to meet AstraZeneca and local regulatory pharmacovigilance requirements.

• Acting as GVP Lead, implementing all elements of Quality management systems related to patient safety (Change Management, Continuous Improvement plan, Issues, Root Cause Analysis, CAPAs, Risks, Self-assessment, Management review meetings, Vendor quality review, PS Agreements, Training & etc.)

• Support delivery of PS training to local staff and locally engaged vendors including annual refresher training.

• Ensures corrective and preventative actions are takenin the event oflocal non-compliance.

• Management of the PV aspects relating to Organised Data Collection Programmes, Digital and Social Media activities, and other arrangements with external parties (such as Externally Sponsored Research (ESR), health authorities’ partnerships, or other collaborations).

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

Requirements:

• Degree in Pharmacy/ Medical/ Science

• Excellent Pharmacovigilance Knowledge

• Deep knowledge of Good Pharmacovigilance Practice

• Deep knowledge of health authority's regulations

• Experience in cross function collaboration

• Leadership skills & act as a role model for the local PS team.

• Project management & experience on above-market PS projects.

• Effective thinking & problem solving

• Vendor management

• Patient Safety systems management.

• Audit & Inspection experience

• Excellent attention to detail

• Excellent written and verbal communication skills

Desirables:

• Advanced scientific degree or equivalent experience

• Extensive Pharmacovigilance Knowledge

• 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

In Office Requirement:

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challengeperceptions.That'swhy we work, on average, a minimum of three days per week from the office. But thatdoesn'tmeanwe'renot 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 recognitionschemeand a competitive, generousremunerationpackage.