Associate Director, Safety Scientist

The Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across multiple product portfolios and/or indicationsOrganizing, training and/or supporting junior safety scientists and fellowsSupporting activities related to new drug applications and other regulatory filingsRepresenting global patient safety at regulatory inspections e.g., MHRA, FDA, EMA, etc.Leading gap analysis to ensure alignment with changes in global regulationsStrategizing and drafting of responses to regulatory inquiries on product safety issues inclusive of defining MedDRA search strategyRepresenting GPS in global program teams and associated cross functional teams and/or projects as neededProactively providing guidance and educational training to GPS therapeutic teamsResponsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical DirectorsPerforming Signal Surveillance activities for respective programs in collaboration with GPS Medical DirectorsProject managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with GPS Medical DirectorsAuthoring safety sections, in collaboration with team members, on regulatory responses, IBs/CCDS, protocols, ICFs, Data Monitoring Committee reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage portfolio of products/projects related to risk management; assists GPS Medical Directors in the development of risk management strategy and activities for assigned productsContribute to on-going process enhancement for safety analytics and reporting, such as developing standard procedures and templatesAssisting GPS Medical Directors to oversee risk minimization activities including tracking of activities as neededMay be directed by the line function to support initiatives outside of their projectsYou must have:Bachelor's degree in a biologic/medical/clinical/nursing fieldAt least 5 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industryKnowledge and understanding of US and EU safety regulations pre- and post- marketingExperience with Risk Management and Minimization programsExperience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management PlansExperience with clinical development including risk/benefit analysis and safety assessmentStrong clinical, analytical, problem solving and scientific writing and communication skillsAbility to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basisExpertise with Microsoft Word, PowerPoint, SharePoint and Excel​Nice to have:Advanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhDExpertise with clinical and safety databasesExperience in MedDRA coding and search strategiesExcellent, independent judgment based on knowledge and expertiseStrong personal time-management and project-management skillsKnowledge of Power BI, and other visualization toolsThe annual base pay ranges from $126,000 to $190,000. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted05-Aug-2026Closing Date18-Aug-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.SummaryLocation: US - Boston - MAType: Full time