Senior Director Deputy QPPV
Welcome to AstraZeneca Patient Safety, aspiring to be the best pharmacovigilance unit in the pharmaceutical industry! Our EU & UK QPPV is looking to recruit a Deputy QPPV for an exciting, impactful, and fun job.
You will be part of a small and well-functioning team of senior pharmacovigilance professionals and at the same time interact and collaborate with other functions across the company. If you are swift to action, able to balance oversight and details, confident in decision-making, willing to collaborate, and curious about what science can do, then you’re our kind of person.
What you’ll do
As the Senior Director, Deputy QPPV you will report directly to the EU & UK QPPV Dr Magnus Ysander and you will be delegated full QPPV responsibilities and authority for part of the products within the AstraZeneca portfolio. You will deputise for the EU & UK QPPV during his absence, taking on the full accountability of the QPPV.
Taking on this role means that you will be involved in all applicable QPPV tasks including, for example: development and maintenance of the safety profile for allocated products; review and approval of Periodic Safety Reports, EU Risk Management Plans, PASS and other relevant documents; advice on management of safety issues and support for responses to requests and questions from regulatory authorities.
You will further be delegated responsibilities for input to and oversight of, for example: the Pharmacovigilance System Master File (PSMF) and Procedural Document (PD), PV Compliance as well as Corrective and Preventive Actions (CAPA) frameworks. You will be collaborating with the Local QPPV and Patient Safety Manager network and contribute to management of Health Authority (HA) inspections and licensing partner audits. Representing the QPPV could be part of your tasks.
Being the Senior Director you will lead the QPPV Office and perform all applicable line manager duties as well as being a member of the QPPV & PV Excellence Leadership Team. You support the development of team strategies and objectives and contribute to the maintenance of team organisation as well as support the competence development of team members.
Essential for the role
Medical Doctor degree, with relevant clinical experience
Extensive experience in Patient Safety in the pharmaceutical industry
Detailed knowledge of relevant PV legislation
Insight in current developments in the pharmaceutical industry
Excellent communication skills
Project management experience
Residency within the EU
Desirable for the role
PhD in scientific field
Expert reputation within the business and industry
Extensive knowledge of the latest technical and regulatory expectations in the PV area
This role is preferable based at our R&D site in Gothenburg, Sweden. Other possible locations are Warsaw, Poland, Barcelona, Spain and Milan, Italy
At AstraZeneca you will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there’s no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It’s our purpose that drives us, every day. Interested? Come and join our journey.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
We will go through the applications continuously so please apply as soon as possible but no later than 9th of October, 2022. Welcome with your application!