Endocyte is a privately held biotechnology company headquartered in the Purdue Research Park in West Lafayette, Ind. We are currently seeking a Drug Safety Associate III to join our team!
The qualified candidate will join our rapidly expanding Indianapolis clinical team and will provide support in the management of adverse events reports, including serious adverse event report from one or more clinical trials including review of safety reports, entry of safety reports into the adverse event reporting system and preparation of safety reports for regulatory authorities. Receives and logs safety reports from sites, reviews them for completeness, and makes a preliminary assessment of the need for expedited reporting based on US regulatory requirements or ICH guidelines.
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Enters safety report data into the Endocyte Serious Adverse Event Report database and uses clinical judgment to code medical terms and drug terms using MedDRA and WHODRUG dictionaries.
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Uses clinical judgment to create draft narratives of adverse events using a standard narrative template.
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In consultation with the Medical Monitor or based on clinical judgment, identifies data requiring further follow up, prepares queries, and submits to clinical sites for completion.
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Prepares summary reports of adverse events for Medical Monitor review.
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Ensures follow-up safety reports are submitted until adverse event resolution or stabilization.
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Notifies Regulatory Affairs and Clinical Operations of reports requiring expedited reporting to regulatory authorities and investigators.
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Coordinates the preparation of expedited safety reports and ensures submission to Regulatory Affairs and Clinical Operations within specified reporting timeframes.
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Acts as liaison with vendors (eg., Contract Research Organizations) performing safety reporting functions on behalf of Endocyte
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Prepares and distributes line listings of safety reports to assist Endocyte Clinical Trial Managers and/or CRAs in the monitoring of adverse events.
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Assists the Medical Monitor in the development of ad hoc reports or summaries of safety data.
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In conjunction with Data Management, reconciles the Endocyte Serious Adverse Event Report database and clinical study database for all safety reports.
Endocyte values our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation annually and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
Send resume to jobs@endocyte.com mail: Endocyte Inc. Attn: Human Resources 3000 Kent Avenue A-1 100 West Lafayette, IN 47906
Fax: 765-463-4621.
URL: www.Endocyte.com
