Principal Pharmacovigilance Scientist Gaithersburg, MD
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 Principal 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
The Principal Pharmacovigilance (PV) Scientist role provides expertise to multiple and/or single but complex products in different stages of development as needed. In this role you will provide oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. You will lead PV strategy for safety documents and regulatory reports.
You will be responsible for leading the strategy for proactive pharmacovigilance and risk management planning of complex or multiple 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 provide subject matter expertise in the therapeutic area and across multiple products.
You may lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization. You will be performing duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products. As a Safety expert you will lead presentation of complex issues to Safety Information Review Committee (SIRC). You will lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
You will lead safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. You will be leading negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements. You will take accountability and lead resolution of complex safety issues and mediate cross-functional agreement.
You may participate in due diligence activities. You will be responsible to provide training and mentorship to new GSPs and PV Scientists in approved processes and systems.
5+ years of directly related PV experience combined with a life sciences/pharmacy/nursing degree, and advanced 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
Advanced 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.