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 / Senior Pharmacovigilance Scientist in Gaithersburg, MD , you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
Main Duties and Responsibilities
As the Senior Pharmacovigilance (PV) Scientist you will lead the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist. You will be responsible to lead and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate. You will lead PS activities of cross-functional project teams for developmental compounds and/or marketed products. You will lead and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports. You will present complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders. You will lead the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products. 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 author/provide strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. 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.
•A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
•Fluent in written and verbal English
•Advanced knowledge of PV regulations
•MD/MSc/PhD in scientific discipline, preferred
•Intermediate understanding of epidemiology, preferred
Next Steps - Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.