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Adverse Event Jobs (NOW HIRING)

Spec Adverse Events

Mundelein, IL · On-site

$67K - $101K/yr

Job Summary The Adverse Event Specialist is responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received ...

Spec Adverse Events

Mundelein, IL · On-site

$67K - $101K/yr

Job Summary The Adverse Event Specialist is responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received ...

Job Summary The Adverse Event Specialist is responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received ...

We are Hiring - Adverse Event Specialist Location: Mundelein, IL (Hybrid Onsite Tuesday Thursday, Remote Monday & Friday) Duration: 3-6 months Pay Range: 25-30/hr We are seeking an Adverse Event ...

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Adverse Event information

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$11

$25

$37

How much do adverse event jobs pay per hour?

As of Jul 27, 2026, the average hourly pay for adverse event in the United States is $25.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $28.61 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Pharmacovigilance (Adverse Event) Specialist, and why are they important?

To thrive as a Pharmacovigilance (Adverse Event) Specialist, you need a background in life sciences or pharmacy, knowledge of regulatory guidelines, and experience in drug safety reporting. Familiarity with safety databases such as Argus or ArisG, as well as understanding of MedDRA coding and ICH-GCP standards, is typically required. Attention to detail, analytical thinking, and strong communication skills help specialists accurately assess and report adverse events. These competencies are crucial for ensuring patient safety, regulatory compliance, and effective risk management in pharmaceutical settings.

What is the difference between Adverse Event vs Clinical Research Coordinator?

AspectAdverse EventClinical Research Coordinator
Required credentialsMedical knowledge, pharmacovigilance trainingResearch ethics, study protocols
Work environmentHealthcare settings, hospitals, clinicsResearch sites, hospitals, clinics
Employer and industry usagePharmaceutical companies, healthcare providersResearch institutions, hospitals
Common search intentUnderstanding safety reportingManaging clinical trials

Adverse Event involves monitoring and reporting negative effects related to medical treatments, requiring medical and pharmacovigilance expertise. Clinical Research Coordinators manage and oversee clinical trials, focusing on study procedures and participant coordination. While both roles operate within healthcare and research environments, their responsibilities and required skills differ significantly.

What is an Adverse Event in the context of healthcare and clinical trials?

An Adverse Event (AE) refers to any undesirable experience or medical occurrence in a patient or clinical trial participant who has been given a pharmaceutical product or is undergoing medical treatment. These events can range from mild side effects to serious health complications and may or may not be directly caused by the treatment itself. Monitoring and reporting adverse events are essential for ensuring patient safety and for regulatory compliance in clinical research. Identifying and documenting AEs helps healthcare professionals assess risks and benefits of medications or treatments and can lead to changes in prescribing information or regulatory actions.

What are some common challenges faced by professionals working in Adverse Event reporting, and how can they be managed?

Professionals in Adverse Event reporting often encounter challenges such as tight regulatory deadlines, the need for meticulous attention to detail, and effective communication with cross-functional teams like clinical, safety, and regulatory affairs. Managing a high volume of reports while ensuring accuracy and compliance can be demanding. To address these challenges, it's important to develop strong organizational skills, stay current on regulatory changes, and build collaborative relationships within your organization. Leveraging technology and standardized processes also helps streamline reporting and ensure timely submissions.
What states have the most Adverse Event jobs? States with the most job openings for Adverse Event jobs include:
Infographic showing various Adverse Event job openings in the United States as of July 2026, with employment types broken down into 86% Full Time, and 14% Part Time. Highlights an 100% In-person job distribution, with an average salary of $53,254 per year, or $25.6 per hour.
Spec Adverse Events

Spec Adverse Events

Medline

Mundelein, IL • On-site

$67K - $101K/yr

Full-time

Medical, Life, Retirement, PTO

Posted 20 days ago


Medline Industries rating

7.5

Company rating: 7.5 out of 10

Based on 249 frontline employees who took The Breakroom Quiz

256th of 535 rated manufacturers


Job description

Job Summary
The Adverse Event Specialist is responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.
Job Description
Responsibilities
  • Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.
  • Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.
  • Work cross-functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.
  • Prepare and submit MDRs through the FDA's electronic submission portal (eMDR) for newly identified reportable events.
  • Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.

Requirements
Education & Work Experience
Bachelor's degree in a relevant field AND 1+ year of experience in complaint handling, MDR evaluation, post-market surveillance, regulatory affairs, or other relevant experience within a regulated industry.
Knowledge / Skills / Abilities
  • Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).
  • Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.
  • Strong analytical and critical-thinking skills with the ability to apply updated decision logic consistently.
  • Effective cross-functional communication and collaboration skills.
  • Ability to manage multiple priorities and meet strict remediation timelines.
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Preferred Requirements
  • 2+ years of experience supporting complaint remediation, MDR reporting, or similar activities within a regulated medical device, pharmaceutical, or healthcare environment.
  • Experience working in environments requiring large-scale retrospective reviews or high-volume documentation processing.
  • Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$67,000.00 - $101,000.00 Annual
The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.

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About Medline

Sourced by ZipRecruiter

Medline Industries, LP is the leading nationwide supplier of medical, surgical and pharmaceutical products to hospitals, nursing homes, HME providers, surgery centers, physician offices and home care/hospice settings.

Industry

Medical equipment and supplies manufacturing

Company size

10,000+ Employees

Headquarters location

Winnetka, IL, US

Year founded

1966