Job Description

Summary: The Scientist role is primarily responsible for aggregate safety analyses and aggregate report writing. He/she will contribute or will be responsible for report writing and/or report ownership related to core safety deliverables including scheduled and ad‑marketing aggregate reports. Daily activities involve database searching, aggregate safety analysis and case‑level review, writing, planning, conducting meetings, and project management/coordination of strategic safety documents. The Scientist will partner with team members, stakeholders such as safety physicians, and a vendor. The Scientist must be able to work on multiple projects simultaneously and prioritize tasks. Responsibilities Serve as report owner or contribute to scheduled and non‑scheduled post‑marketing safety reports and other deliverables as applicable. Prepare scheduled reports such as PBRERs/PSURs, PADERs, addendums to Clinical Overview, and PBRER/PSUR addendum reports. Prepare non‑scheduled reports including ad‑hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labeling support documents. Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate. Initiate and conduct searches of internal and external databases. Perform aggregate safety analysis and case‑level review; present results at Safety Management Team meetings as needed. Author and contribute to the preparation of core safety deliverables. Partner with vendor to develop reports/deliverables. Comply with processes and ensure appropriate documentation. Utilize technical skills and programs (e.g., Excel pivot tables, SAS, JMP) to analyze and organize data. Adhere to report timelines and elevate issues to management as appropriate. Qualifications Bachelor’s degree in health or biomedical science with 3+ years industry experience (or equivalent), or Advanced degree in health or biomedical science with 2+ years industry experience (or equivalent). Clinical/medical writing and/or PV experience. Strong English verbal and written communication skills. Preferred Qualifications Aggregate safety report writing and aggregate safety analysis experience. Project management of safety/regulatory documents. Awareness of applicable regulations and guidance related to post‑marketing aggregate safety requirements. Experience using Microsoft Word templates. Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr

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