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Adverse Event Reporting Remote Jobs in Kentucky (NOW HIRING)

Schulte Companies

Remote Staff Accountant

Louisville, KY · On-site +1

$50K - $66K/yr

... event tickets, electronics, gym memberships + more! Our Company: SHG is a leading third-party ... Run, review and distribute month end owner's reports for assigned portfolio based on ownership ...

Schulte

Remote Staff Accountant

Louisville, KY · On-site +1

$52K - $69K/yr

... event tickets, electronics, gym memberships + more! Our Company: SHG is a leading third-party ... Run, review and distribute month end owner's reports for assigned portfolio based on ownership ...

Schulte Companies

Remote Staff Accountant

Louisville, KY · On-site +1

$50K - $66K/yr

... event tickets, electronics, gym memberships + more! Our Company: SHG is a leading third-party ... Run, review and distribute month end owner's reports for assigned portfolio based on ownership ...

Sierra Club

Chapter Director

Louisville, KY · Remote

Remote within Kentucky Reports To : Deputy Regional Field Director Supervises: Chapter staff ... Ensures the Chapter and its leaders participate in meetings, task forces, and events. Builds strong ...

Sierra Club

Chapter Director

Owensboro, KY · Remote

Remote within Kentucky Reports To : Deputy Regional Field Director Supervises: Chapter staff ... Ensures the Chapter and its leaders participate in meetings, task forces, and events. Builds strong ...

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Adverse Event Reporting Remote information

What is adverse event reporting in a remote role?

Adverse event reporting in a remote role involves monitoring, documenting, and submitting reports about any negative or unintended effects experienced by patients during clinical trials or after using pharmaceutical products. Remote professionals in this field collect data from various sources, assess the severity and causality of the events, and ensure timely communication with regulatory authorities. The work is performed off-site using secure digital systems, requiring strong attention to detail, regulatory knowledge, and adherence to confidentiality protocols.

What are the key skills and qualifications needed to thrive in adverse event reporting remote, and why are they important?

To thrive in Adverse Event Reporting remotely, you need a solid understanding of pharmacovigilance principles, data analysis, and regulatory requirements, typically supported by a degree in life sciences or healthcare. Familiarity with safety databases like Argus or MedDRA coding, and experience using electronic reporting systems are essential. Attention to detail, strong written communication, and the ability to work independently are crucial soft skills for this role. These skills ensure accurate reporting, regulatory compliance, and timely identification of drug safety concerns, all of which protect patient health and company reputation.

What are some common challenges faced by professionals in remote adverse event reporting roles, and how can they be addressed?

Remote Adverse Event Reporting professionals often encounter challenges such as maintaining clear and timely communication with cross-functional teams, ensuring data accuracy without in-person supervision, and staying up-to-date with evolving regulatory requirements. To overcome these, it is important to establish strong communication routines, utilize secure digital platforms for collaborative documentation, and regularly participate in virtual training sessions. Being proactive about asking questions and seeking feedback can also help ensure compliance and high-quality reporting in a remote setting.

What is the difference between Adverse Event Reporting Remote vs Clinical Data Coordinator?

AspectAdverse Event Reporting RemoteClinical Data Coordinator
Required credentialsLife sciences degree, certification in pharmacovigilance preferredHealthcare or life sciences degree, data management certifications
Work environmentRemote, primarily computer-based, often independentOffice or remote, involves data entry and management
Employer and industry usagePharmaceutical companies, CROs, biotech firmsHospitals, research institutions, pharma companies
Common search and comparison intentUnderstanding remote pharmacovigilance rolesManaging clinical data in research settings

Adverse Event Reporting Remote focuses on monitoring and reporting drug safety incidents remotely, requiring pharmacovigilance knowledge. Clinical Data Coordinators manage clinical trial data, often in healthcare or research settings. While both roles involve data handling, Adverse Event Reporting Remote emphasizes safety reporting, whereas Clinical Data Coordinators focus on data accuracy and integrity in clinical studies.

What are popular job titles related to Adverse Event Reporting Remote jobs in Kentucky?

For Adverse Event Reporting Remote jobs in Kentucky, the most frequently searched job titles are:

What job categories do people searching Adverse Event Reporting Remote jobs in Kentucky look for?

The top searched job categories for Adverse Event Reporting Remote jobs in Kentucky are:

What cities in Kentucky are hiring for Adverse Event Reporting Remote jobs?

Cities in Kentucky with the most Adverse Event Reporting Remote job openings:

Adverse Event Reporting Remote jobs near you
Infographic showing various Adverse Event Reporting Remote job openings in Kentucky as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, 1% Temporary, 4% Contract, and 1% Nights. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution.

Sr Quality Manager

Lexington, KY • Remote

Keystone & Golden, Inc.
Fitness and Sports Centers • 1 - 10 employees
Learn more about Keystone & Golden, Inc.external

Full-time

Re-posted 14 days ago

Job description

About the Company

Our client is a rapidly growing consumer health and wellness company that has quickly become a category leader in functional oral pouch products. Backed by top-tier consumer investors, industry operators, and professional athletes, the company is redefining performance-focused products through science-backed innovation and premium quality standards.

This is a unique opportunity to join a high-growth organization during a pivotal stage of expansion and help build the quality infrastructure that will support future growth.

Position Summary

The Senior Quality Manager will lead quality systems across the entire supply chain, from raw material suppliers and contract manufacturers to distribution and consumer complaint management.

This is a highly visible "build" role responsible for establishing and scaling quality processes, supplier qualification programs, audit systems, and complaint management procedures that ensure compliance with 21 CFR Part 111 and applicable dietary supplement regulations.

Reporting directly to executive leadership, this individual will serve as the quality subject matter expert and play a critical role in protecting product integrity, regulatory compliance, and consumer trust.

Key Responsibilities

Quality Systems & Compliance

  • Maintain and continuously improve the Quality Management System (QMS), including SOPs, specifications, batch records, deviations, CAPA, and change control processes.
  • Ensure compliance with 21 CFR Part 111 and applicable dietary supplement regulations.
  • Partner with Product Development and Operations on specifications, stability programs, and product release testing.
  • Drive a culture of continuous improvement and quality excellence.

Contract Manufacturer Audits

  • Develop and execute a risk-based audit program across all manufacturing partners.
  • Conduct on-site and remote GMP audits evaluating quality systems, documentation practices, sanitation programs, and manufacturing controls.
  • Issue audit reports, track CAPAs, and verify timely closure of findings.
  • Maintain audit readiness across all operational facilities.

Consumer Complaint Management

  • Build and manage an end-to-end complaint handling system.
  • Establish investigation workflows, escalation procedures, and adverse event reporting processes.
  • Lead root cause investigations and CAPA implementation.
  • Monitor complaint trends and provide actionable insights to Quality, Regulatory, and Product Development teams.

Supplier Qualification

  • Develop and manage supplier qualification and approval programs.
  • Review specifications, Certificates of Analysis, identity testing requirements, and supplier documentation.
  • Conduct supplier risk assessments and maintain Approved Supplier Lists.
  • Manage supplier performance monitoring, requalification activities, and change control processes.

Qualifications

Required

  • Bachelor's degree in Chemistry, Food Science, Microbiology, or related scientific discipline.
  • 5+ years of quality experience within dietary supplements, food, pharmaceuticals, or consumer products.
  • Experience leading or supporting supplier qualification programs and GMP audit initiatives.
  • Strong working knowledge of:
    • 21 CFR Part 111
    • GMP requirements
    • CAPA systems
    • Complaint handling processes
    • Supplier quality management
  • Experience implementing or managing quality tracking and complaint management systems.
  • Strong investigative, problem-solving, and root-cause analysis skills.

Preferred

  • Experience with oral pouch, buccal, or alternative delivery systems.
  • ASQ certifications such as CQA, CQM, CQE, or equivalent.
  • Experience supporting high-growth consumer products or dietary supplement organizations.