Associate Director Patient Safety Spain

Associate Director Patient Safety Spain

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 world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

We are looking for a professional expert in the Patient Safety function, equipped with a profound understanding of local health authority regulations and EU GVP requirements. They will oversee and manage all patient safety-related processes, activities, issues, and gaps at multi-country level, taking charge of necessary actions to address them effectively.

The Associate Director Patient Safety contributes to the core components of the local pharmacovigilance system, thus ensuring AZ and Alexion Rare Disease Unit (RDU) has in place an effective pharmacovigilance system that complies with the EU and local PV requirements. 

You will report into the Director, Patient Safety Cluster Lead Southern Europe and be part of the Global Patient Safety Organisation.

Main tasks and responsibilities:

• The role involves line management of local Patient Safety team for Spain and Portugal, providing leadership and contributing to the Patient Safety organization by overseeing various activities and leading projects or segments of larger international initiatives, while also managing risks through evaluative judgments in complex situations.
• For Spain responsibility as deputy Local Contact Point, comply with local legislation Royal Decree 577/2013 of July 26, regulating the Pharmacovigilance of Medicinal Products for Human Use, assisting the qualified person responsible for pharmacovigilance in the European Union referred to in Article 8.3 in his/her assigned functions and cooperate in the tasks described in the Article 14 of this Royal Decree.
• Represents Patient Safety on cross-functional teams and steering committees related to the country and within the global patient safety organization
• 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.)
• Maintains an in-depth knowledge of their local authority, the regulations, expectations and regulatory authority contacts and ensures that upcoming changes in legislation/guidance are notified to their regional lead for discussion and escalation to relevant stakeholders in the organisation as required
• Participate in the preparation and local implementation of EU Risk Management Plans and additional Risk Minimization Measures.
• Lead PV audits and be the ‘deputy’ point of contact for GVP inspections in Spain.
• Review and oversight of Organize Data Collection Programs such as Market Research, Non-Interventional Studies, Patient Support Programs and Early access programs in Spain
• Contribute to the setting up of local Safety Agreements with collaborative partners.
• Provide PV awareness training to internal employees and vendors.
• Ensures a local Business Continuity Process (BCP) for Patient Safety is in place and tested at least annually.
• Ensures that all local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF):
• Coordinates and maintains oversight of PS activities done by vendors for the country.
• Oversight the local vendor for PV activities in Spain and its budget allocation;
• Oversees the vendor for the collection of AEs from every source into AE form, AE Intake tool or Argus and, as appropriate

• People Management: Accountable for People management and development;
• 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.
• Identify team training needs and commit resources to ensure development initiatives are delivered.

Ensure team development by updating Individual development plans for each team member and providing support to accomplish the plans.

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 AstraZeneca's voice is heard in discussions about the regulatory needs of our product portfolio in terms of patient safety.

Your Profile:

• University degree in pharmacy, life sciences or related discipline.
• 10y Experience in Bio/pharmaceutical industry within the Pharmacovigilance space.
• Demonstrated ability to work independently and in project settings to deliver objectives.
• Able to lead trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments.
• Strong communication, leadership and line management and influencing skills.
• Fluency in Spanish and English language required. 

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Please apply by submitting your CV via our global career website.

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.