Principal Patient Safety Scientist in Vaccines & Immune Therapies (V&I) At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 Principal Patient Safety Scientist in Vaccines & Immune Therapies (V&I), you will play a pivotal role in channelling our scientific capabilities to make a positive impact on patient's lives. In this exciting and challenging role, you will be involved in aggregating, reviewing, analysing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protecting patients. You will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians playing a role supporting the safety strategy and requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.
You will join us in driving development of our innovative and emerging pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. You will be representing the voice of patients in the development, maintenance and use of our medicines.
Main Duties and Responsibilities As Principal Patient Safety Scientist V&I, you will provide expertise to multiple and/or single but complex products in different stages of development as needed. In your role, your contributions and impact will be great! Your day to day will include:
Provide oversight of safety documents & deliverables for these projects in collaboration with scientists and the Global Safety PhysicianLead the PV strategy for safety documents and regulatory reportsEnsure proactive pharmacovigilance and risk management planning of complex or multiple products to include:Preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSPProvide subject matter expertise in the therapeutic area and across multiple productsLead cross-functional process improvement or other initiatives on behalf of the Patient Safety organizationPerform required activities as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple productsBe recognized as a Safety expert and lead presentation of complex issues to Safety Information Review Committee (SIRC)Lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelinesLead safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional expertsLead negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreementsAccountable for and will lead resolution of complex safety issues and mediate cross-functional agreementsMay participate in due diligence activitiesResponsible for ensuring training is provided and mentorship is assigned to new GSPs and PV Scientists within the established systems & processesWhat We Are Looking For We look for demonstrated leadership skills and application of your advanced PV knowledge and experience. We need a Principal Patient Safety Scientist who has a passion for customers, thinks strategically, acts decisively, works collaboratively and can be integral to the development of our people and organization.
BS degree in life sciences related field5+ years of directly related PV experience combined with life sciences/pharmacy/nursing training and advanced Patient Safety and/or Clinical Drug Development experience.Fluent in written and verbal EnglishAdvanced knowledge of PV regulationsPreferred Qualifications MD/MSc/PhD in scientific disciplineAdvanced understanding of epidemiologyWhy AstraZeneca At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next: Are you already envisioning yourself joining our team? Good, because we can't wait to hear from you.
Competitive salary and benefits package on offer. The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, a performance recognition scheme and a competitive, generous remuneration package.
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