Analyst, Clinical Safety
Analyst, Clinical Safety
Posted on :
09-08-2025
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1 Vacancy
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Job Description
- Triages incoming SAE information in order to fulfill timely reporting according to the authority/regulatory requirements.
- Participate in safety surveillance activities for assigned products; and also in area projects/goals. Identify and escalate problems to manager.
- Collecting analyzing and triaging Adverse Events including reporting Serious Adverse Events to IND safety including follow-up.
- Timely assessment of adverse event coding for consistency and accuracy of coding.
- Timely accurate and effective medical review of safety-related CRFs and labs including communication with Study Designated Physicians.
- Interface with study manager Clinical Research Organizations Clinical Research Associates Data Management and Pharmacovigilance to assure query resolution.
- Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.
- Work closely with study-specific contacts such as; Clinical Safety Manager clinical research organization clinical research associates data management and pharmacovigilance.
- Responsible for clinical safety capture and report as workload responsibilities are study-related and have a major impact on regulatory compliance and product safety profile.
- Follow scientific arguments and identify safety data needs and adhere to resolution of data completeness regarding all aspects of clinical safety that impact product approval safety signal identification and patient safety.
Qualifications :
- Bachelors degree with related health science background preferred RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelors degree but with previous pharma experience may be additionally considered.
- 2 years clinical experience is required.
- Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.
- Sound understanding of product labeling/literature including safety profile.
- Able to apply clinical knowledge to adverse event data collection and assessment.
- Competent in ability to present adverse event data orally and in writing.
- Adheres to policies and regulations.
- Must be Computer proficient (Windows Word Excel).
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
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