Senior Clinical Safety Analyst

Summary

Join AbbVie's Clinical Trial Patient Safety Organization and contribute to the evaluation and quality assurance of clinical trial patient safety data. This role involves worldwide surveillance of clinical trial patient safety data and continuous improvement efforts. Responsibilities include assessing reported clinical trial data, independently reviewing and analyzing safety-related data, maintaining effective communication with key stakeholders, and ensuring audit readiness. You will also supervise the tracking of safety-related queries, collaborate on study safety reviews, and provide safety overviews to various teams. The position requires participation in protocol reviews and report creation, along with staying current on regulatory guidance. This remote-eligible position offers opportunities for process improvement and mentoring.

Requirements

• Bachelor's degree with related health science background
• A minimum of 4 years’experience to include at least 2 years of clinical practice experience
• 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
• Demonstrated ability to lead study management activities
• Effective communication skills in delivering study-related information

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 independent 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
• Aligns and maintains effective communication channels with key clinical, medical, study team, including CTPS manager, regulatory, compliance, and pharmacovigilance counterparts
• Maintains constant state of audit readiness for study deliverables
• Supervises the tracking of safety-related queries to Investigators, ensuring appropriate closure
• 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 as a representative for CTPS on cross functional projects
• Supports department, division and company's strategic direction by demonstrating the Abbvie “Ways We Work”leadership behaviors
• Demonstrates knowledge and expertise through mentoring of new CTPS team members on assigned safety activities
• Identifies areas of improvements in process and brings forth ideas to leadership

Preferred Qualifications

• RN or clinical pharmacy experience strongly preferred
• 2 year drug safety experience with clinical trial life cycle management –Pre-clinical to Phase III through launch to market is preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs