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Adverse Event Jobs in Texas (NOW HIRING)

Onnit Labs, Inc.

Quality Specialist

Austin, TX · On-site

Adverse Event Management: Supports the review, sign-off, investigation, trending, and escalation of adverse events and serious adverse events in accordance with internal procedures and regulatory ...

YO AI Labs

Hematology Expert - Remote

Houston, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

YO AI Labs

Hematology Expert - Remote

Austin, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

YO AI Labs

Oncology Expert - Remote

Dallas, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

YO AI Labs

Hematology Expert - Remote

Dallas, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

YO AI Labs

Clinicia Expert - Remote

Dallas, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

YO AI Labs

Clinicia Expert - Remote

Austin, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

YO AI Labs

Clinicia Expert - Remote

Houston, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

YO AI Labs

Oncology Expert - Remote

Austin, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

YO AI Labs

Oncology Expert - Remote

Houston, TX · Remote

$150 - $200/hr

Assess dose escalation strategies, dose-limiting toxicities, adverse event grading, attribution, and patient safety narratives. * Review benefit-risk assessments and identify clinically inconsistent ...

Winaxis

Clinical Research Coordinator

Dallas, TX · On-site

$24 - $32/hr

Report adverse events and serious adverse events according to protocol and regulatory requirements. * Coordinate with investigators, sponsors, CROs, and ethics committees. * Prepare for monitoring ...

Winaxis

Clinical Research Coordinator

Dallas, TX · On-site

$24 - $32/hr

Report adverse events and serious adverse events according to protocol and regulatory requirements. Coordinate with investigators, sponsors, CROs, and ethics committees. Prepare for monitoring visits ...

Heartflow

Director - Post Market Quality

Austin, TX

You will lead the Designated Complaint Handling Unit, Product Investigations team, global adverse event reporting (FDA MDR, EU Vigilance), field actions, and the post-market surveillance processes ...

Socket.dev

Director - Post Market Quality

Austin, TX · On-site

$200 - $250/hr

Adverse Event Reporting * Own reportability decision- making and timely submission of FDA Medical Device Reports under 21 CFR Part 803, including 30- day, 5- day, and supplemental reports. * Own ...

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Adverse Event information

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.

What are popular job titles related to Adverse Event jobs in Texas?

For Adverse Event jobs in Texas, the most frequently searched job titles are:

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

The top searched job categories for Adverse Event jobs in Texas are:

Adverse Event jobs near you
Infographic showing various Adverse Event job openings in Texas as of August 2026, with employment types broken down into 78% Full Time, 17% Part Time, and 5% Temporary. Highlights an 100% In-person job distribution.

Quality Specialist

Onnit Labs, Inc.

Austin, TX • On-site

Full-time

Posted 19 days ago

Job description

JOB SUMMARY

The Quality Specialist is an essential member of the Quality Assurance team, responsible for maintaining the highest quality standards throughout the testing, release, and distribution of dietary supplements. This role requires a deep understanding and competency in 21 CFR Part 111 and 117. Key responsibilities include overseeing document control, change control, complaint management, tracking and trending adverse events and NCR/CAPA investigations to ensure compliance and product safety.

KEY RESPONSIBILITIES

  • QMS System Proficiency: Demonstrates strong working knowledge of QMS platforms and related processes, including document management, complaint management, CAPAs, non-conformances, training, and quality records.
  • Adverse Event Management: Supports the review, sign-off, investigation, trending, and escalation of adverse events and serious adverse events in accordance with internal procedures and regulatory expectations.
  • Data Trend Analysis: Tracks, analyzes, and summarizes quality data to support risk-based decision-making, continuous improvement, and management review activities.
  • Third-Party Certification Testing: Coordinates and tracks testing activities required for third-party certifications, ensuring timely completion, accurate documentation, and effective communication of results.
  • Training Management: Maintains training matrices and training records to ensure employees are appropriately trained on applicable SOPs, controlled documents, forms, and GMP requirements.
  • Training Facilitation: Coordinates and facilitates employee training sessions to support compliance with company policies, applicable procedures, and regulatory requirements.
  • Document Control: Maintains controlled documents and ensures proposed changes are routed through the appropriate review and approval process prior to implementation.
  • Change Control: Manages and monitors change control activities to ensure changes to products, processes, or documentation are appropriately assessed, approved, implemented, and documented in accordance with internal quality standards and applicable regulatory requirements.

QUALIFICATIONS

  • Minimum of a bachelor's degree from an accredited four-year college or university in a related field, or an equivalent combination of education, training, and experience that provides the required knowledge, skills, and abilities.
  • 3+ years of relevant quality assurance experience in the food, dietary supplement, or related regulated industry.
  • Working knowledge of dietary supplement and food quality requirements.
  • Understanding of warehouse operations, manufacturing processes, and quality system requirements.
  • Experience using and managing activities within Veeva QMS or a comparable quality management system.
  • Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint, as well as Google Workspace tools.
  • PCQI certification or working knowledge of Preventive Controls requirements preferred.

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