Director, Patient Safety Excellence QPPV Office

Are you passionate about patient safety and always looking for quality and compliance excellence and opportunities for continuous process improvement?  If you a true believer of the relevance of having robust processes and oversight in place for the ultimate goal of providing medicines with optimal benefit/risk balance to patients, this opportunity is for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Join us in the QPPV Office team as a Director Patient Safety Excellence.  Help us reach our goal of having the best possible pharmacovigilance system.  This is an excellent chance to be part of a global high-performing and influential team working in a true collaborative environment.  

This role will be based at our Gothenburg site, one of AstraZeneca's three strategic science centers. We thrive in a multinational environment working cross-functionally across the globe with AstraZeneca colleagues as well as academic and industry partners. Our way of life is to foster a working environment that nurtures, collaboration, openness and innovation. Therefore, we have created space for meetings, socializing and relaxation, where spontaneous meetings can give birth to new innovations. The unexpected ideas or thoughts that can come from a chat over something as simple as a cup of coffee or a stroll on our “walk and talk” meeting trail.

At AstraZeneca, Global Patient Safety (GPS) is at the forefront of defining and optimizing the safety profile of our medicines across their lifecycle in all therapeutic areas. GPS leads the way in integrating science, data, and technology to shape clinical safety strategies. From monitoring and detection to characterization and reporting of adverse events, GPS plays a critical role in ensuring the safety of our medicines for patients worldwide. The QPPV Office is a central part of GPS driving gold standard pharmacovigilance quality, compliance and efficiency across AstraZeneca.

What you’ll do

You will be acting as Pharmacovigilance senior expert  continually strengthen the QPPV reach and influence internally and externally, thus driving gold standard pharmacovigilance quality, compliance and efficiency across AstraZeneca.  You will be supporting the QPPV in triaging topics that require awareness, assessment and decision making for processes for which you will become main point of contact toward business process owners, patient safety teams and representatives from other function. You will lead and drive continuous improvement projects relevant to the scope of the QPPV function. You will be managing additional tasks relevant to the QPPV role and responsibilities as per existing and upcoming regulatory requirements and internal needs which includes training, compliance and PSMF related activities.  You will be as needed required to support audit and inspections activities.

Essential for the role

• 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 

• Good knowledge and comprehension of relevant pharmacovigilance legislation 

• Excellent medical writing and communication skills 

• Experience and ability to develop and implement new standards and best practices 

• Strong project management skills 

• Proven ability to lead teams and collaborate in a continuous improvement  
• Good strategic thinking capability 

Desirable for the role

• Regulatory strategy knowledge and experience 

• Clinical development knowledge and experience 

• Lean Sigma experience 

Why AstraZeneca?
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 challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Build unrivalled capabilities in a place that promotes learning and agility and offers development opportunities. We never stand still. You’ll have the chance to grow your abilities, skills, and knowledge constantly. Here we are a fusion of challenging and exciting work in an energizing and inspiring environment.

Embrace the opportunity for development – whether it’s upskilling or reskilling. We are a high-performing learning organization with autonomy over how we learn. We deliver innovative development experiences that sustain and grow future leaders and talent. Because we want all our people to embrace the challenges and opportunities ahead. This is the place to build a fulfilling, long-term career.

Ready to make a difference? Apply now!

Date Posted

31-mars-2025

Closing Date

13-apr.-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.