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Adverse Event Jobs (NOW HIRING)

Procom

Product Safety Lead

Raleigh, NC · On-site

Product Safety Lead - The Product Safety Lead is responsible for overseeing the collection, processing, follow-up, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs ...

Mindlance

Medical Reviewer/Safety Reviewer II

Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment. Ability to present accurate and medically sound safety data, both ...

Talent Groups

Drug Safety Specialist

Waltham, MA · Hybrid

Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational ...

Talent Groups

Drug Safety Specialist

Waltham, MA · Hybrid

Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational ...

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How much do adverse event jobs pay per hour?

As of Sep 9, 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 is an adverse event?

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 the key skills and qualifications needed to thrive as a pharmacovigilance (adverse event) specialist?

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 are 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 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.

More about Adverse Event jobs

What states have the most Adverse Event jobs?

States with the most job openings for Adverse Event jobs include:

What job categories do people searching Adverse Event jobs look for?

The top searched job categories for Adverse Event jobs are:

Adverse Event jobs near you
Infographic showing various Adverse Event job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $53,254 per year, or $25.6 per hour.

Regulatory Affairs Manager

Niles, IL • On-site

KOBAYASHI HEALTHCARE INTERNATIONAL INC
51 - 200 employees
Learn more about KOBAYASHI HEALTHCARE INTERNATIONAL INCexternal

$150 - $200/hr

Other

Re-posted yesterday

Job description

Job DetailsJob Location: NILES - Niles, IL 60714Salary Range: $1.00 - $2.00 SalaryThe significant responsibilities of the position are listed below. To perform the job successfully, the individual must be able to execute each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other duties, assignments and specific projects may be assigned at the discretion of management.

Duties and ResponsibilitiesRegulatory Strategy & Compliance
  • Develop and implement regulatory strategies for OTC monograph drug products, cosmetics, dietary supplements, and Class I medical devices.
  • Interpret and apply applicable FDA regulations, guidance documents, enforcement policies, and industry standards.
  • Assess regulatory impact of new product concepts, formulations, claims, labeling, and packaging.
  • Ensure ongoing compliance with FDA requirements and applicable state regulations.
Product Development Support
  • Partner with R&D, Marketing, and Quality teams during product development and commercialization.
  • Review product formulations, ingredients, specifications, and labeling for regulatory compliance.
  • Provide regulatory guidance on product claims, advertising, promotional materials, websites, and digital content.
  • Support innovation initiatives by identifying regulatory pathways and requirements for new products.
Labeling & Claims Review
  • Lead regulatory review and approval of product labels, packaging artwork, instructions for use, and promotional materials.
  • Evaluate structure/function claims, cosmetic claims, OTC drug claims, and device-related claims.
  • Ensure labeling complies with applicable FDA regulations and industry standards.
Regulatory Documentation & Submissions
  • Prepare and maintain regulatory documentation and compliance records.
  • Support FDA registrations, product listings, establishment registrations, and related regulatory filings as required.
Quality & Risk Management
  • Collaborate with Quality Assurance to support audits, inspections, investigations, CAPAs, and change control activities.
  • Assess regulatory risks and provide mitigation strategies.
  • Monitor and communicate regulatory changes that may impact existing or future products.
Cross-Functional Leadership
  • Serve as the primary regulatory resource for internal stakeholders.
  • Provide training and guidance on regulatory requirements and compliance best practices.
  • Support supplier qualification, ingredient reviews, and regulatory due diligence activities.
Post-Market Surveillance & Adverse Event Reporting
  • Manage and oversee adverse event reporting programs for OTC drug products, dietary supplements, cosmetics, and medical devices in accordance with FDA requirements.
  • Evaluate consumer complaints, adverse events, and safety reports for reportability and regulatory impact.
  • Ensure timely submission of required reports, including Serious Adverse Event Reports (SAERs), Medical Device Reports (MDRs), and other applicable regulatory notifications.
  • Partner with Quality, Consumer Relations, and Legal teams to investigate product complaints and safety signals.
  • Maintain adverse event documentation, complaint files, and post-market surveillance records in compliance with applicable regulations.
  • Monitor product safety trends and recommend corrective and preventive actions when necessary.

Support regulatory inspections, audits, and inquiries related to post-market surveillance and adverse event reporting.

Knowledge, Skills & Abilities
  • Strong understanding of FDA regulatory frameworks and enforcement trends.
  • Excellent analytical and risk assessment capabilities.
  • Ability to interpret complex regulations and translate them into practical business guidance.
  • Strong project management and organizational skills.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborative leadership style with strong stakeholder management skills.
QualificationsRequired Qualifications:
  • Bachelor's degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or a related field.
  • 5+ years of regulatory affairs experience in FDA-regulated consumer healthcare products.
  • Demonstrated experience with OTC monograph drug products, cosmetics, dietary supplements, and/or medical devices.
  • Strong knowledge of:
  • FDA OTC Monograph regulations
  • FD&C Act requirements
  • Dietary Supplement Health and Education Act (DSHEA)
  • Cosmetic regulatory requirements under MoCRA
  • Class I Medical Device regulations
  • Product labeling and claims compliance
  • cGMP requirements
Preferred Qualifications:
  • Advanced degree in scientific discipline, regulatory affairs, or related field.
  • Regulatory Affairs Certification (RAC).
  • Experience working with contract manufacturers and private label products.
  • Experience supporting FDA inspections and regulatory audits.
  • Experience managing adverse event reporting, complaint handling, and post-market surveillance programs for FDA-regulated products.
  • Working knowledge of FDA requirements for Serious Adverse Event Reporting (SAER), Medical Device Reporting (MDR), and cosmetic adverse event reporting requirements under MoCRA.
  • Experience conducting regulatory assessments of consumer complaints, product safety issues, and reportable events.
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