Note: The job is a remote job and is open to candidates in USA. AbbVie, through its Allergan Aesthetics portfolio, develops innovative medicines and solutions for serious health issues. The Clinical Safety Analyst contributes to worldwide surveillance of clinical trial patient safety data by assessing and analyzing safety information, supporting study safety reviews, preparing safety reports and narratives, and ensuring adherence to regulatory guidance. The role also supports audit readiness, clinical team communications, and process improvement initiatives.
Responsibilities
- Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review and contribution to ad-hoc Safety Reports as needed
- Provide review and analysis of safety-related data from clinical trials for content, quality, potential study level trend identification, and adherence to regulatory guidance and protocols utilizing critical thinking skills
- Maintains constant state of audit readiness for study deliverables
- Monitoring of safety-related queries to Investigators
- In collaboration with medical monitor, plans and executes the plan for study safety review
- Provides safety overview to the clinical team, Clinical Research Organizations, Investigators and investigator sites as needed
- Participates in review of study protocols to ensure appropriate safety language
- Review safety sections of the clinical study reports, and other ad-hoc reports which include safety data
- Creates narratives of serious adverse events and other identified events of interest in accordance with accepted standards
- Current with knowledge of ICH, FDA, and EMA regulatory guidance’s affecting safety surveillance
- May serve on departmental process improvement projects
- Supports department, division and company's strategic direction by demonstrating the Abbvie “Ways We Work” leadership behaviors
Skills
- Bachelor's degree with related health science background
- Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases)
- Ability to critically evaluate medical data understanding the clinical course and treatment modalities
- Effective communication skills in delivering study-related information
- RN or clinical pharmacy experience strongly preferred
- A minimum of 2 years' experience to include at least 2 years of clinical practice experience
- A preferred 1-year drug safety experience with clinical trial life cycle management – Pre-clinical to Phase III through launch to market
Benefits
- Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
- Eligible to participate in short-term incentive programs
Company Overview
Company H1B Sponsorship