This position is contributing to world-wide surveillance of clinical trial patient safety data and continuous
improvement efforts.
Core Job Responsibilities include:
- 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.
- Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred.
- A minimum of 2 years’ experience to include at least 2 years of clinical practice experience and a preferred 1-year drug safety experience with clinical trial life cycle management – Pre-clinical to Phase III through launch to market.
- 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.
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.
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