Patient Safety Scientist 10/9/2017

AstraZeneca Pharmaceuticals LP Gaithersburg, MD

Gaithersburg, MD
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


b Location: /b Cambridge, br England, br United Kingdom br Gaithersburg, br Maryland, br United States br b Job reference: /b R-011313 br br b Posted date: /b Oct. 06, 2017 p b Patient Safety Scientist /b /p p b Location, Cambridge /b /p p b Salary, Competitive /b /p p At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing. br /p p Our Patient Safety teams offer a unique opportunity to work on end to end safety programmes from pre-clinical, first time in humans, through to late stage and submission. Rather than working on routine case handling our Scientists and Physicians are regarded as strategic and deeply involved in the science. The combination pipeline we have provides a unique intellectual challenge to the safety teams and requires a broader portfolio management approach to projects br /p p This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. Patient Safety sits within Global Medicines Development (GMD) where we have a crucial role to play. Faced with complex disease challenges, we’re focused on exceptional performance to drive the best and most transformative drug programmes ever. br /p p The Patient Safety (PS) Scientist role works collaboratively with the Global Safety Physician (GSP) and (Senior/Principal) PS Scientist with the review of safety data and related documents for potential safety issues. He/she has the ability to provide authoring and PS input to safety documents and regulatory reports. PS Scientist also has the ability to lead meetings and present safety data and analyses. /p p b R /b b esponsibilities will include: /b /p p You will 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. /p p Representing PS on cross-functional project teams for developmental compounds and/or marketed products. Have the ability to present safety information at external meetings and to perform duties as a Safety Strategy and Management Team (SSaMT) leader for smaller or less complex projects. /p p Present issues to Safety Information Review Committee (SIRC) and has the capacity to take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders. /p p Producing accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data. /p p Collaborate with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for assigned development products; coordinates meetings and tracks timelines to ensure completion. /p p 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. /p p You will author/provide strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines, as well as input to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. /p p Contributing to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreement as well as training junior members of the team in PS tools and systems b . /b /p