Senior Medical Safety Officer USA

Senior Medical Safety Officer USA – Washington, D.C. Be a part of a revolutionary change At PMI, we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose – to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. Our success depends on people who are committed to our purpose and have an appetite for progress. Your ‘day to day’: As a Senior Medical Safety Officer US, you will be responsible to manage and oversee the medical safety activities of PMI smoke-free products in the United States, for both pre and post-market setting. You will be part of the Medical Safety Office in Product Safety Surveillance (PSS) Team, with direct report to US Head of Regulatory. More specifically you will: • Build a product safety and risk management of PMI SFPs in the US for the first time, beginning with no program to having a program fully functional within 6-9 months • Refine the product safety and risk management program to strengthen it over time so that it is robust and surpasses regulatory requirements • Perform medical assessment of serious adverse events originating from the US post market setting and occurring in clinical trials • Lead the implementation of country specific safety surveillance plans, including signal detection and risk management activities • Collaborate with US cross-functional teams to ensure that safety-related issues are identified and managed appropriately • Ensure safety training of applicable US functions • Act as primary contact point for any safety related questions coming from the local regulatory authority (i.e., FDA) • Ensure that safety risks are assessed and mitigation plans are put in place. Ensure that safety information is communicated effectively to internal and external stakeholders, including regulatory authorities and consumers with oversight from the Head of Medical Safety Office • Ensure compliance with regulatory requirements and guideline, including FDA and other relevant international guidelines (e.g., GVP) • Act in compliance with applicable internal standards/procedures • Support the Head of Medical Safety Office with establishment and implementation of PMI medical safety related policies, procedures and programs related to assessment studies in humans for RRPs and post-market setting • Provide review of Safety Update Reports and other safety medical documents • Provide guidance to US safety scientists. Who we’re looking for: • Medical Doctor • Minimum 5 years’ experience in a leading pharmacovigilance/safety role in pharmaceutical, biotech or tobacco company • Extensive knowledge of global pharmacovigilance/safety regulations and guideline, including FDA regulations and guidelines • In-depth knowledge of product safety and risk management that allows creating such program from scratch • Excellent communication and interpersonal skills, with ability to built effective relationships with stakeholders • Strong analytical and problem-solving skills • Experience with signal detection and risk management activities is preferred • Legally authorized to work in the U.S.. Annual Base Salary Range: $160000 - $220000 What we offer • We offer a competitive base salary, annual bonus (applicable based on level of position), great medical, dental and vision coverage, 401k with a generous company match, incredible wellness benefits, commuter benefits, pet insurance, generous PTO, and much more! • We have implemented Smart Work, a hybrid model of working that promotes flexibility in the workplace. • Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore. • Be part of an inclusive, diverse culture where everyone’s contribution is respected; Collaborate with some of the world’s best people and feel like you belong. • Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress. • Take pride in delivering our promise to society: a smoke-free future. PMI is an Equal Opportunity Employer PMI Global Services Inc. and PM Global Brands Inc. are a subsidiary of Philip Morris International Inc. Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, its shareholders and its other stakeholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products, associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group, Inc. for sale under license in the U.S., where these products have received marketing authorizations from the U.S. Food and Drug Administration (FDA) under the premarket tobacco product application (PMTA) pathway; the FDA has also authorized the marketing of a version of IQOS and its consumables as a Modified Risk Tobacco Product (MRTP), finding that an exposure modification order for these products is appropriate to promote the public health. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of September 30, 2022, PMI's smoke-free products are available for sale in 70 markets in key cities or nationwide, and PMI estimates that approximately 13.5 million adults around the world, excluding Russia and Ukraine have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com. #LI-Hybrid