Why choose AstraZeneca Spain?
AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.
We invite you to bring your talents to Barcelona where our respiratory medicine R&D and Global Marketing centre offers opportunities in R&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology & CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world-leading pipeline of therapeutics and delivering life-changing medicines to patients.
Who do we look for?
Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.
Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.
Success Profile
Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.
Diverse collaborators
This is a speak-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast-paced collaboration, you’ll always be building new connections with colleagues.
Cutting-edge innovators
When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.
Resilient trailblazers
Here, the answers aren’t always available. So, you’ll need to bring a fearless, self-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.
Agile movers
Seize ownership and excel with autonomy to enjoy the constant rush of ground-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.
Responsibilities
Location: Barcelona, Spain (on-site) 3 days working from the office / 2 days working from home
- Act as QPPV Pharmacovigilance (PV) Expert, continually strengthen QPPV oversight of the pharmacovigilance system, reach and influence internally and externally, thus driving gold standard pharmacovigilance quality, compliance and efficiency for AstraZeneca.
- In support of PV Excellence, manage and oversee QPPV Office deliverables; for example Pharmacovigilance System Master File (PSMF), Summary of Pharmacovigilance System (SPS), AstraZeneca profile in EudraVigilance and PRAC output monitoring,
- Contribute to continuous improvement projects relevant to the scope of the QPPV function.
Typical Accountabilities
- Deliver according to the QPPV Office Operating Model to ensure PV System Quality and Compliance and strengthen QPPV oversight and influence. This includes, but is not limited to, the following activities:
- Coordinate, manage and drive the review and update of the Pharmacovigilance System Master File (PSMF)
- Triage and handling of PSMF & PRAC oversight related matters requiring QPPV input and/or awareness.
- Monitor PRAC outputs as per SOP and guidelines.
- Develop standardised best practice, templates, authoring, instructions and guidance for production of Patient Safety outputs in relation to e.g., PSMF.
- As relevant interpret and validate current, new and changing legislation and contribute to interpretation and impact analysis
- Contribute to the EU QPPV’s management and oversight of the PV Quality System.
- Coordination and ownership of the lifecycle management of nominated processes (for example; EU QPPV Standard and PSMF and SPS Standard Operating Procedure (SOP).
- Maintain and improve, as relevant, reporting tools and analysis processes to facilitate pharmacovigilance oversight.
- Provide process training to CMO staff and other functional groups, including the PSMF Coordinator back up, as necessary.
- Coordinate and manage AstraZeneca’s profile in EudraVigilance, including oversight of user access (Trusted Deputy role).
- Provide specialist knowledge and support to be recognised as an expert and source of reference for safety teams and other stakeholders.
- Upon request participate in and/or support activities for GVP audits/inspections.
- Undertake other nominated tasks as requested; for example contribution to and coordination of projects led by the QPPV Office
- Work collaboratively with other skill groups or functions to ensure alignment of activities and priorities, sharing of best practices, etc.
- Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
- Seek personal and professional development opportunities, and share knowledge gained
Education, Qualifications, Skills and Experience
Essential
- Life science degree (MD, PharmD, RPh, RN, or related degree) or master’s degree in life sciences, or related field
- Extensive experience in patient safety/pharmacovigilance including applicable industry experience and seen as a subject matter expert
- Extensive operational experience in production of core safety outputs
- Good knowledge and comprehension of relevant pharmacovigilance legislation
- Excellent medical writing skills
- Excellent communication skills
- Experience and ability to develop and implement new standards and best practices
- Project management skills
- Proven ability to lead teams and collaborate in a continuous improvement
- Strategic thinking capability
- Good knowledge of the AZ organization
Desirable
- Regulatory strategy knowledge and experience
- Clinical development knowledge and experience
- Lean Sigma experience
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.
Reasons to Join
Thomas Mathisen
There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.
Christine Recchio
Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.
Stephanie Ling
There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.
What we offer
We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, inclusivity, balance and sustainability. Discover what a career at AstraZeneca could mean for you.
An award-winning company
We're passionate about being a great place to work, and 84% of our employees would recommend us as an employer. We've been recognised as a Top Employer in Spain, an EFR Family Responsible Business, and we achieved third place in Forbes Spain's Top 50 Best Places to Work list.
Inclusive environment
Diversity and inclusion are embedded in everything we do, and our different views, experiences and strengths enrich our culture. There's no salary gap at AstraZeneca, and the number of female employees has increased by four per cent over the last three years. We've also made all positions fully accessible.
Work-life balance
Your wellbeing means a lot to us, and we're here to support you through all of life's ups and downs. That's why we offer an unpaid leave policy, annual leave, reduced-hours timetables and a host of benefits, including a retirement plan, long service award, and health and travel insurance.
Sustainability initiatives
We're committed to harnessing the power of science to become a more sustainable business. We've reduced our carbon footprint by over 9,000 kg of CO2 over the last two years, and we lead the European GoGreen Project, which aims to introduce environmentally friendly options in our fleet of corporate vehicles.
We’ll keep you up to date
