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About the Role
This position supports the Clinical Trial Patient Safety Organization to achieve its mission of evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery of high-quality relevant and timely data review. Contributes to a culture of process improvement, innovation, and cross-functional teamwork aligning with the company vision and strategies.
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.
Requirements
- 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.
- Fluency in Japanese and business-level English, with the ability to communicate effectively with local and global stakeholders.
Skills
- Critical thinking
- Computer proficiency (Windows, Word, Excel)
- Database proficiency (oracle/clinical, PIMS, laboratory databases)
- Medical data evaluation
- Communication skills
- Japanese fluency
- Business-level English
Experience Level
- Minimum of 2 years’ experience
- At least 2 years of clinical practice experience
- Preferred 1-year drug safety experience
Education Level
- Bachelor's degree with related health science background
- RN
- Clinical pharmacy experience
About the Company
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal Opportunity
- AbbVie is an equal opportunity employer, committed to integrity, driving innovation, making a remarkable impact on people's lives, and contributing to the community.
- We actively support individuals with disabilities towards equal employment opportunities.