Neuchatel, Switzerland


Life Sciences



Job ID


Medical Safety Officer – Neuchatel, Switzerland 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 smoke-free products. 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. It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products. Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free and beyond nicotine future. Your ‘day to day’ As a Medical Safety Officer, you will provide robust medical safety expertise for assigned products through lifecycle management of products. More specifically, you'll • Oversees all processes that lead to the production of safety sections and content of relevant clinical study documents including protocols, investigator’s brochure, informed consent forms, safety management plan, study reports, any post-hoc analysis, publications or presentations. • Ensure training is provided to all relevant partners and functions on all related procedures in the context of trials. Provides guidance on medical safety topics raised by internal/external clinical study team, clinical sites or others, in a clear, concise and timely manner. • Perform medical assessment of serious cases from both studies and spontaneous sources, including additional follow-up information as necessary; provide support as needed for identification of reportable cases to regulatory authorities and/or ethics committees. • Follow the established requirements, processes and plans related to safety signal detection, performs medical review of signal reports, aggregate safety analysis and contribute to development/update of reference safety information for allocated products. • Ensure seamless integration with multiple teams and departments to support development of products assessment. • Actively contribute to the team duties, such as maintenance and improvement of processes, GCP/GVP/legislation trainings, managerial reporting, and team presentations, as well as to the business continuity of the medical safety duties by acting as medical back-up to other officers engaged in assessment studies or in post marketing safety surveillance activities. • Act in compliance with applicable internal standards/procedures as well as regulations (e.g. GVP, GCP) and any other specific regulatory requirements. Who we’re looking for • Medical Doctor Degree • Demonstrated experience in medical safety acquired in industry, CRO or academia, as well as in medical devices or medical monitoring activities and knowledge with regards to safety signal detection. • Additional expertise gained through education, experience and training in at least one of the following domains: pharmaceutical medicine, pharmacovigilance, clinical pharmacology, pharmacokinetics, nicotine replacement therapy/smoking cessation • Good knowledge of ICH CGP (track record of GCP trainings) and pharmacovigilance related standards and rules in the USA, European Union and Japan. • Proficient in written and verbal English. What we offer Our success depends on the people who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: • 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. #LI-Hybrid