At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Sr. Pharmacovigilance Scientist in Gaithersburg, MD or Cambridge UK, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Chief Medical Officer's Office drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
Do you have expertise in, and passion for Patient Safety and Pharmacovigilance. Would you like to apply your expertise to impact Pharmacovigilance in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one 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.
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
Global Patient Safety are the AstraZeneca patient safety experts responsible for the safety of our products throughout the phases of clinical development and after authorization. We work proactively throughout the drug's life cycle, from pre-clinical via clinical development to post-marketing, contributing to strategically designed studies and cutting edge safety surveillance to characterize the safety profile of our medicines. We monitor patient safety across studies, across projects and across different therapy areas through the science of detection, assessment, understanding and prevention of safety issues. We evaluate the totality of the available data with a focus on science, and an in-depth understanding of regulations, guidelines and global markets.
The Sr. Pharmacovigilance (PV) Scientist role works collaboratively with the Global Safety Physician (GSP) and (Senior/Principal) PV Scientist with the review of safety data and related documents for potential safety issues. He/she has the ability to provide authoring and PV input to safety documents and regulatory reports. PV Scientist also has the ability to lead meetings and present safety data and analyses.
What you'll do
As the Senior Pharmacovigilance (PV) Scientist in Gaithersburg, MD, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives through the following:
- You will lead the review of safety data and related documents for potential safety issues and conduct proactive pharmacovigilance and risk management planning for a drug program in partnership with the product global safety physician and others as appropriate.
- You will provide strategic PS leadership and expertise on cross-functional project teams for a drug program and contribute to activities for regulatory submissions, the Investigator Brochure, Protocols, Informed Consents and Clinical Study Reports.
- You will present complex issues to Safety Information Review Committee (SIRC) and take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
- You will author/provide strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
- You will participate in negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
- You will train and mentor junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.
Essential for the role
- A life sciences/nursing/pharmacy degree.
- Demonstrated Patient Safety and/or Clinical/Drug Development and/or research experience.
- Scientific curiosity and a life- long learner mentality
- Fluent in written and verbal English.
Desirable for the role
- MSc/PhD in scientific discipline, preferred
- Advanced knowledge of PV regulations
- Intermediate understanding of epidemiology
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. 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.
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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