Future Opportunities - Join Our Talent Pipeline for Clinical Safety Analyst (CSA)

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.

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 Clinical Safety Analyst role is integral to AbbVie’s mission of evaluating and ensuring quality of clinical trial patient safety data. The primary objective of this role is to deliver a high level of safety data accuracy contributing to worldwide surveillance of clinical trial patient safety.

Responsibilities:

• Timely assessment of reported clinical trial patient safety data, also participating in review and contribution to safety surveillance activities of assigned studies.
• Analysis of safety-related clinical trial data for completeness, medical congruency and trend identification.
• Maintenance of audit-ready state for study deliverables.
• Issuance of and monitoring of safety-related queries to investigators.
• Collaboration with medical monitors, planning and executing the study safety review.
• Providing study teams and medical monitors with safety overviews.
• Review of study protocols to ensure inclusion of appropriate safety language.
• Reviewing safety sections of clinical study reports and preparation of ad-hoc reports with safety data.
• Creation of narratives for serious adverse events and other events of interest complying for analysis and the clinical study report.
• Staying current with ICH, FDA, and EMA regulatory guidance impacting safety surveillance.
• Role in cross-functional and departmental process improvement projects.

• Bachelor's degree with a health science background is required. RN, clinical pharmacist, Physician Assistant or MD/MBBS experience is strongly preferred.
• At least 2 years of clinical practice experience working with patients is required. One year drug safety experience preferred.
• Ability to critically evaluate medical data and understand the clinical course and treatment modalities.

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, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html