Senior Pharmacovigilance Scientist - RIA
AstraZeneca has an opening for Pharmacovigilance Scientist in Gaithersburg, MD and Waltham MA
Are you ready to drive development of our innovative Respiratory and Immunology pipeline? AstraZeneca holds a unique position in Respiratory Disease, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development, leveraging novel combinations, biologics and devices.
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 Pharmacovigilance Scientist in Gaithersburg, MD or Waltham MA you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
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.
The Chief Medical Office (CMO) is an integrated, enterprise-wide organization dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining their health authority approvals around the world, and ensuring they are accessible for patients. The CMO mission is:
- Provide a scientific and strategic perspective on the safe development, maintenance and use of our medicines
- Foster a culture of continuous improvement and quality, defining global standards for medical and scientific activities
- Ensure consistent strategic, technical and operational regulatory support across the enterprise
- Be a trusting, inclusive and innovative organisation, that attracts, develops and retains the best and brightest
- Advocate the patient perspective on the development and ethical use of our medicines
What you’ll do
We are currently seeking a Pharmacovigilance (PV) Scientist to join our Respiratory Disease Global Patient Safety Team. The 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. The PV Scientist has the ability to provide authoring and PV input to safety documents and regulatory reports. PV Scientist may also lead meetings and present safety data and analyses. Main responsibilities include, but not limited to:
- Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of safety aspects of Global Risk Management Plans, in partnership with the GSP and others as appropriate.
- Represents PS on cross-functional project teams for developmental compounds and/or marketed products.
- Has the ability to present safety information at external meetings.
- Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects.
- Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
- Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
- Authors/provides strategic input to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Essential for the role
- 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
Desirable for the role
- Advanced degree in scientific discipline
- Basic understanding of epidemiology data
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 organisation 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! (select one Call to Action -CTA text)
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Next Steps – Apply today!
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
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.