Drug Safety Associate

Wilmington, DE

Posted: 04/11/2023 Industry: Scientific Job Number: 23-00151

Job Description

Job Summary (Primary function)
The Drug Safety Associate will be responsible for data entry of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials

Essential Functions of the Job (Key responsibilities)
Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for marketed products and clinical trials.
Completion of the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions.
Perform case processing and data gathering tasks within Argus Safety Database and other systems (i.E. EDC systems).
Ensure compliance with internal procedures, regulatory requirements, and partner agreements to ensure inspection readiness at all times.
Maintain files and systems as appropriate.
Completion of additional tasks and projects as assigned by management.

Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree in a science or healthcare related discipline (nursing/pharmacy preferred), or equivalent.
Minimum of 2 years pharmacovigilance experience or other equivalent clinical or pharmaceutical experience.
Experience using safety database systems (Argus experience preferred).
Strong knowledge of global Pharmacovigilance regulations (CFR/GVP), ICH Guidelines and Good Clinical Practices.
Excellent computer skills (i.E. Microsoft Word, Excel, Outlook, and Power Point).
Ability to work effectively within a team environment.
Solid organizational, time management, and problem-solving skills.
Excellent verbal and written communication skills.
Fluency in written and verbal English.
Ability to travel to office for monthly departmental meetings at assigned offices as well as for ad hoc meetings and/or urgent matters (notice period: 24 hours or less) as needed.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.


Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Meet Your Recruiter

Richard Vigliotti

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