Job Title: Associate Director, Patient Safety Scientist
Location: Luton, UK
Salary: Competitive + Excellent Employee Benefits!
Applications Deadline: May 8th
Introduction to role
Are you ready to make a difference in the world of oncology? As an Associate Director, Patient Safety Scientist, you will play a pivotal role in ensuring the safety of our innovative treatments. Reporting to the Global Safety Program Lead (GSPL) or Global Safety Head (GSH), Patient Safety Oncology, you will be collaborating closely with the GSPL, Safety Physician, and other PV Scientists, you will review safety data and documents to identify potential safety issues. Your expertise will be crucial in authoring safety documents and regulatory reports, leading meetings, and presenting safety data and analyses. Join us in our mission to eliminate cancer as a cause of death!
Accountabilities:
- Lead proactive pharmacovigilance and risk management planning for designated products, including preparing safety aspects of Global Risk Management Plans.
- Represent Patient Safety on cross-functional project teams for developmental compounds and/or marketed products.
- Present safety information at external meetings.
- Perform duties as required in Safety Strategy and Management Team (SSaMT).
- Present issues to the Safety Information Review Committee (SIRC) and lead data evaluation discussions.
- Produce accurate evaluation documents with clear conclusions for internal or regulatory authority requests.
- Collaborate with Patient Safety colleagues and Clinical representatives to author Reference Safety Information (RSI) for assigned development products.
- Evaluate clinical implications of safety data from various sources to establish drug safety profiles and manage patient risk.
- Author or provide strategic input for periodic regulatory documents (PBRERs, PSURs, DSURs) according to agreed timelines.
- Contribute to regulatory submissions for new products, formulations, or indications in partnership with GSP and other experts.
- Ensure quality and integrity of agreements in the PS component of contracts with third parties.
- Train team members in PS tools and systems.
Essential Skills/Experience
- A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/Drug Development experience.
- Intermediate knowledge of PV regulations.
- Fluent in written and verbal English.
- MD, MSc/PhD in scientific discipline, preferred.
- Basic understanding of epidemiology data, preferred.
Desirable Leadership Skills:
- Passion for Customers: Engage with customers to ensure delivery of complete solutions.
- Think Strategically: Use knowledge and experience to challenge and adapt current approaches.
- Act Decisively: Make effective decisions under pressure and seek support when needed.
- Drive Performance: Hold team accountable to quality standards by clarifying objectives and timelines.
- Work Collaboratively: Integrate diverse views by seeking input and incorporating cross-functional perspectives.
- Develop People and Organisation: Provide support and feedback to junior staff while continuing personal development.
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.
At AstraZeneca, we are driven by a shared passion to learn, grow, and discover. Our scientific community is unrivalled, seamlessly fusing academia and industry. We celebrate successes and learn from the best while embracing opportunities to build meaningful careers. With female leaders in 45% of senior roles internally and 475 pre-clinical collaborations across 26 countries externally, we are committed to improving lives through groundbreaking research.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.
We encourage you to apply online before May 8th.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Ready to join us on this exciting journey? Apply now to be part of our team dedicated to pioneering new frontiers in oncology!
Date Posted
30-Apr-2025Closing Date
09-May-2025Our 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.