Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.
In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.
The role of Clinical Safety Analyst (CSA) 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.
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.
Qualifications
Clinical Safety Analyst roles require the following:
- 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.
Senior Clinical Safety Analyst titles require the following:
- Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred.
- A minimum of 4 years’ experience to include at least 2 years of clinical practice experience. In addition, 2 year drug safety experience with clinical trial life cycle management – Pre-clinical to Phase III through launch to market is preferred.
- 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
Additional Information
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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