Pharmacovigilance Scientist US - Gaithersburg - MD/en-US/Careers/job/US---Gaithersburg---MD/Pharmacovigilance-Scientist_R-032793/apply 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 peoples exceptional skills with those of people from all over the globe. As a Pharmacovigilance Scientist in Gaithersburg, MD, youll 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 holds a unique position in Respiratory Disease, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development by leveraging novel combinations, biologics and devices. The pipeline also has a number of promising assets in inflammatory and autoimmune diseases within areas such as psoriasis, psoriatic arthritis, gout, systemic lupus and rheumatoid arthritis. Main Duties and Responsibilities As a 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. Essential Requirements * 3 + years in 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! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them. 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. Date Posted 26-Jul-2018 Closing Date Posted 3 Days AgoFull timeR-032793 AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. Were inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process. Youll be part of a team thats rolling back the frontiers of science to turn yesterdays impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients and in return, well help you develop way beyond what you thought possible.