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 hoc post-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 Scientist would be responsible to contribute to or serve as report owner for scheduled and non-scheduled post-marketing safety reports and other deliverables as applicable. Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labelling support documents.
Ensure timely, quality deliverables for assigned tasks related to core deliverables with oversight as appropriate. Initiate/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/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 to analyze and organize data (eg, Excel pivot tables, SAS JMP). Adhere to report timelines and escalate issues to management as appropriate.
Educational Qualification/ Experience Required: Bachelor's degree in health or biomedical science (3+ years industry experience or equivalent) or Advanced degree preferred in health or biomedical science (2+ years industry experience or equivalent). Clinical/medical writing and/or PV experience. Strong English verbal and written communication skills. Aggregate safety report writing and aggregate safety analysis. Project management of safety/regulatory documents. Awareness of applicable regulations and guidances related to post-marketing aggregate safety requirements. Experience using Microsoft word templates.
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