{"id":3006414,"url":"https://alion.io/job/astrazeneca-associate-director-safety-scientist","title":"Senior Manager, Safety Scientist","company":{"id":13195,"name":"AstraZeneca","domain":"astrazeneca.com","url":"https://alion.io/company/astra-zeneca","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":92,"open_postings":129,"ghost_share":0,"stale_share":0.496,"repost_share":0.07,"time_to_fill_p50_days":19,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":132000,"max":190000,"currency":"USD","period":"year","gross":null,"usd_annual":190000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Power BI","optional":true}],"status":"live","first_seen_at":"2026-10-21T13:56:51Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-28T12:04:11Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":6},"description":"The Senior Manager, Safety Scientist plays a pivotal role within Global Patient Safety to actively evaluate and manage safety risks in close collaboration with the 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.\nYou will be responsible for:\nContributing to safety data reviews and analyses for products in designated therapeutic areas\nAuthoring 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 documents\nCoordinating, preparing, and completing high-quality aggregate safety reports (e.g., PSUR, PBRER, PADER) for submission to regulatory agencies globally\nEnsuring the oversight of safety for assigned assets, including implementation and execution of the Safety Strategy and Management Team (SSaMT) and Safety Surveillance Team (SST)\nLeading 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 results.\nAuthoring and project management of health authority queries\nMaintaining accountability for the authoring, review and finalization (i.e., endorsement, sign-off) of risk management plans and contributing to REMS documents\nAssisting GPS Medical Directors in the development of risk management strategy\nTraining and/or managing junior safety scientists and fellows\nSupporting 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 labels\nAssisting Global Safety Physicians in developing a strategy for safety-related regulatory activities\nProactively managing safety documents by driving timely execution, engaging cross-functional stakeholders, and ensuring adherence to safety governance and regulatory timelines Supporting continuous improvement in safety analytics and reporting by contributing to the development of standardized procedures and templates\nRepresenting global patient safety as a subject matter expert in clinical study teams and cross-functional meetings \nContributing to initiatives for process improvement and cross-departmental process consistency\nMaintaining a strong, up-to-date working knowledge of evolving global regulations \nYou will have:\nBachelor’s degree in a biologic/medical/clinical/nursing field\nAt least 3 years' experience in drug safety/pharmacovigilance\nKnowledge of global pharmacovigilance regulations\nStrong analytical and problem-solving skills\nExcellent communication and interpersonal skills\nStrong scientific writing skills\nDemonstrated learning agility and ability to work independently\nSound judgement\nAbility to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis\nBasic understanding of downstream regulatory, patient, business, and reputational impact of PV actions\nThe 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.\nNice to have:\nAdvanced degree in a biologic/medical/clinical/nursing field preferred: Pharmacist/PharmD, Nurse Practitioner or PhD \nExperience preparing aggregate safety reports and conducting signal surveillance\nExperience with clinical development including risk/benefit analysis and safety assessment\nExpertise with clinical and safety databases\nExperience in MedDRA coding and search strategies\nStrong personal time-management and project-management skills\nExperience with data visualization tools (e.g., Power BI, Spotfire)\nProject leadership, organizational, and prioritization skills\nThe annual base pay ranges from $132K 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.\nDate Posted\n23-Oct-2026Closing Date\n29-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. 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