Clinical Safety Analyst (Remote)

AbbVie; Chesapeake (VA); Remote; USD 70,000 - 100,000; Full time

Job summary

AbbVie is seeking a Clinical Safety Analyst who will support the Clinical Trial Patient Safety Organization by ensuring the quality of patient safety data. Responsibilities include assessing reported clinical trial data, participation in safety surveillance, and providing safety oversight to various stakeholders. The ideal candidate will have a background in health sciences and critical thinking skills to analyze clinical trial data effectively.

Benefits

Paid time off (vacation, holidays, sick)

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Qualifications

• Bachelor's degree with related health science background.
• 2+ years of clinical practice experience.
• Proficiency in Computers (Windows, Word, Excel).

Responsibilities

• Provides timely assessment of reported clinical trial data.
• Maintains constant state of audit readiness for study deliverables.
• Review safety sections of clinical study reports.

Skills

Critical Thinking

Data Analysis

Effective Communication

Education

Bachelor's degree in Health Science

Tools

Oracle/Clinical

PIMS

laboratory databases

Job 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 Tik Tok .

Job Description

This Clinical Safety Analyst 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.

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.
• Supports department, division and company's strategic direction by demonstrating the Abbvie “Ways We Work” leadership behaviors.

This role can be remote in the US.

Qualifications

• Minimum Requirements:* Bachelor's degree with related health science background* 2+ years of clinical practice experience
• Preferred Experience/Education:
  • RN or clinical pharmacy experience strongly preferred
  • Drug safety experience with clinical trial life cycle management – Pre-clinical to Phase III through launch to market.
• Other Required Skills:* 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

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 incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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.

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

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.