Clinical Safety Analyst (Remote)

Lensa; Chicago (IL); Remote; USD 64,000 - 122,000; Full time

Job summary

A leading career site is seeking a Clinical Safety Analyst for AbbVie. This role involves evaluating and ensuring the quality of clinical trial patient safety data, promoting process improvement and teamwork. Candidates should have a Bachelor's degree in a health science field and at least 2 years of clinical practice experience. The position can be remote in the US.

Benefits

Paid time off

Insurance

401(k)

Participation in incentive programs

Qualifications

• At least 2 years of clinical practice experience.
• RN or clinical pharmacy experience preferred.
• Experience with drug safety throughout clinical trial phases.

Responsibilities

• Assess reported clinical trial data and participate in safety surveillance activities.
• Review and analyze safety data for content, quality, trends, and regulatory adherence.
• Collaborate with medical monitors to plan and execute safety reviews.

Skills

Proficiency with Windows

Proficiency with Word

Proficiency with Excel

Ability to evaluate medical data

Effective communication skills

Education

Bachelor's degree in a health science field

Tools

Oracle/Clinical

PIMS

lab databases

Job description

Lensa is the leading career site for job seekers at every stage of their career. Our client, AbbVie, is seeking professionals. Apply via Lensa today!

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 X, Facebook, Instagram, YouTube, LinkedIn, and TikTok (https://www.tiktok.com/@abbvie).

Job Description

This Clinical Safety Analyst supports the Clinical Trial Patient Safety Organization to evaluate and ensure the quality of clinical trial patient safety data through timely and accurate data review. The role promotes process improvement, innovation, and teamwork, aligning with the company's vision.

This position involves worldwide surveillance of clinical trial safety data and continuous improvement efforts.

Core Job Responsibilities Include

1. Assess reported clinical trial data and participate in safety surveillance activities, including review and contribution to Safety Reports.
2. Review and analyze safety data for content, quality, trends, and regulatory adherence.
3. Maintain audit readiness for study deliverables.
4. Monitor safety-related queries to Investigators.
5. Collaborate with medical monitors to plan and execute safety reviews.
6. Provide safety overviews to clinical teams, CROs, Investigators, and sites.
7. Review study protocols for safety language.
8. Review safety sections of clinical study reports and other safety data reports.
9. Create narratives for serious adverse events following standards.
10. Stay current with ICH, FDA, and EMA safety guidance.
11. Participate in departmental process improvements.
12. Support strategic directions demonstrating AbbVie's leadership behaviors.

This role can be remote in the US.

Qualifications

Minimum Requirements:

• Bachelor's degree in a health science field.
• At least 2 years of clinical practice experience.

Preferred Experience/Education:

• RN or clinical pharmacy experience preferred.
• Experience with drug safety throughout clinical trial phases, from pre-clinical to market.

Other Required Skills:

• Proficiency with Windows, Word, Excel, and databases like Oracle/Clinical, PIMS, lab databases.
• Ability to evaluate medical data and understand clinical courses and treatments.
• Effective communication skills for study-related information.

Additional Information

Salary range: $64,000 - $122,000. Benefits include paid time off, insurance, 401(k), and participation in incentive programs. Compensation depends on location and other factors.

AbbVie is an equal opportunity employer committed to diversity and inclusion. For more details, visit this link.