Job Description
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. The pioneers, we make bold moves that transform the way cancer is treated and truly improve patient outcomes. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next. What you'll doThe Director, Principal Patient Safety Scientist within Oncology Patient Safety is the highest level individual contributor scientist in our team structure before a team member elects to stay in technical project facing tract or moving into leadership tract leading and managing individuals within our organization. We are looking for someone who can demonstrate leadership within our environment and lead on complex PV projects through safety science expertise. You will lead PV strategy for complex products in different stages of development through input and delivery of safety documents and regulatory reports. Your duties and responsibilities are likely to include:
Responsibilities + Skills
MAA/BLA SubmissionsPeriodic ReportsRisk Management Plans (from scratch)
Education
A degree in life sciences (or similar field) and advanced Patient Safety and/or Clinical/Drug Development experienceExcellent written and verbal EnglishAdvanced knowledge of PV regulations
Experience