Job Description

The Associate Director, Safety Scientist plays a pivotal role within Global Patient Safety, providing strategic leadership and project management to proactively evaluate and manage safety risks in close collaboration with GPS Medical Director(s) and cross-functional team members throughout the lifecycle of assigned product(s). You will operate according to the highest ethical, quality and compliance standards as provided by global and local regulations, GxP practice and AZ procedures. You will report to the Director, Safety Scientist, GPS and be based in Boston, MA.You will be responsible for:Leading safety data reviews and analyses for products in designated therapeutic areasAuthoring or reviewing safety sections of clinical documents including but not limited to the clinical study protocol, informed consent form, Investigator’s Brochure, statistical analysis plan, clinical study report, and data monitoring committee documentsCoordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globallyEnsuring the oversight of safety for assigned assets, including implementation and execution of the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST)Leading program and study level safety surveillance including the analysis and communication of safety data, authoring of internal safety review documents, presentation at cross-functional decision-making bodies and documentation/tracking of all signal analysis resultsLeading the authoring and project management of health authority queriesMaintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documentsAssisting GPS Medical Directors in the development of risk management strategyRepresenting global patient safety at regulatory inspections (e.g., MHRA, FDA, EMA)Mentoring, training and/or managing junior safety scientists and fellowsSupporting activities related to new drug applications and other regulatory filings including authoring, reviewing and providing input to eCTD modules (2.5 and 2.7.4), core product information (i.e., CCDS), and local labelsAssisting Global Safety Physicians in developing a strategy for safety-related regulatory activitiesProactively managing safety documents by driving timely execution, engaging cross-functional stakeholders, and ensuring adherence to safety governance and regulatory timelinesSupporting continuous improvement in safety analytics and reporting by contributing to the development of standardized procedures and templatesRepresenting global patient safety as a subject matter expert in clinical study teams and cross-functional meetingsContributing to initiatives for process improvement and cross-departmental process consistencyMaintaining a strong, up-to-date working knowledge of evolving global regulationsYou will have:Bachelor’s degree in a biologic/medical/clinical/nursing fieldAt least 5+ year experience in pharmaceutical industry in drug safety/pharmacovigilanceSubject matter expertise in global pharmacovigilance regulations Experience preparing aggregate safety reports and conducting signal surveillanceExperience with clinical development including risk/benefit analysis and safety assessmentStrong analytical and problem-solving skillsExcellent communication and interpersonal skillsStrong scientific writing skillsDemonstrated learning agility and ability to work independentlyAbility to apply decision-making principles to contribute to key scientific/clinical discussionsSound, independent judgement based on knowledge and expertiseAbility to interact effectively with colleagues of multiple disciplines and cultures both within and outside the company on a global basisUnderstanding of the downstream regulatory, patient, business, and reputational impact of PV actionsThe duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.​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 strategiesStrong personal time-management and project-management skillsExperience with data visualization tools (e.g., Power BI, Spotfire)Advanced project leadership with strong organizational and prioritization skillsExperience with various roles in drug safety (e.g., case processing, operations)Mastery of Microsoft Word, PowerPoint and ExcelThe annual base pay ranges from $126K to $190K. 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 Posted07-Oct-2026Closing Date20-Oct-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

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