Senior Director Deputy Qppv
hace 1 mes
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 in external associations and meetings 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 contribute to the maintenance of team organisation as well as support the competence development of team members.
**Essential for the role**
- Medical Doctor or relevant Life Science degree
- Extensive experience in Patient Safety in the pharmaceutical industry, preferably as EU QPPV or Deputy
- 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 can be located at our Gothenburg, Sweden R&D site and also in our offices in Barcelona, Spain or Warsaw, Poland.
**Why AstraZeneca?**
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.
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