AbbVie

Clinical Safety Analyst

AbbVie • $88K — $105K *
US-AnywhereRemote in North Chicago, IL
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a health science field; RN or clinical pharmacy preferred.
  • Minimum of 2 years' clinical practice experience, with ideally 1 year in drug safety during clinical trial life cycle.
  • Proficient in relevant software such as Windows, MS Word, MS Excel, and specific clinical databases.
  • Skilled in critically evaluating medical data and understanding clinical treatments.
  • Strong communication skills for conveying study-related information.

Responsibilities

  • Assess reported clinical trial data promptly and engage in safety surveillance for assigned studies.
  • Review and analyze safety data for quality and regulatory compliance using critical thinking.
  • Maintain audit readiness for study deliverables at all times.
  • Monitor safety-related queries received from Investigators.
  • Collaborate with medical monitors to plan safety review strategies for studies.
  • Provide safety overviews to clinical teams, organizations, and investigator sites as required.
  • Ensure safety language is accurate during the review of study protocols.
  • Create narratives for serious adverse and other important events per accepted standards.

Benefits

  • Comprehensive medical, dental, and vision insurance.
  • Paid time off including vacation and sick leave.
  • 401(k) plan for eligible employees.
  • Participation in short-term incentive programs.
Full Job Description
Job Description

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.
  • 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
  • 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.


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.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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