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Adverse Event Reporting Jobs (NOW HIRING)

Zimmerman Associates Inc.

Analyst Coder I

Mundelein, IL · On-site

Analyst Coder I Zimmerman Associates, Inc. (ZAI) is seeking an Analyst Coder I to support adverse event reporting and safety data management activities within the FDA Adverse Event Reporting System ...

Masimo

Sr MDR Specialist

Irvine, CA · On-site

Lead and manage Medical Device Reporting (MDR), vigilance, and adverse event reporting activities in accordance with FDA, EU MDR, and other applicable global regulatory requirements. * Review, assess ...

Masimo

Sr MDR Specialist

Irvine, CA

Lead and manage Medical Device Reporting (MDR), vigilance, and adverse event reporting activities in accordance with FDA, EU MDR, and other applicable global regulatory requirements. * Review, assess ...

millenniumsoft

Clinical Risk Specialist I

Covington, GA · On-site

$83K/yr

Preferred experience with FDA regulated industry in complaint handling and MDR/adverse event reporting. Experience with Microsoft Office. Preferred experience in complaint handling software and Excel ...

Pacer Group

Product Safety Lead

Raleigh, NC · On-site

Post Marketing Adverse Event Processing: Ability to independently analyze and accurately process adverse event reports from all sources, for medical devices, cosmetics and OTCs. This includes an ...

millenniumsoft

Clinical Risk Specialist I

Covington, GA · On-site

The Clinical Risk Specialist I will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, and analyze adverse events/complaint trends. Summary ...

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How much do adverse event reporting jobs pay per hour?

As of Jun 7, 2026, the average hourly pay for adverse event reporting 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 in the Adverse Event Reporting position, and why are they important?

To thrive in Adverse Event Reporting, you need a solid background in life sciences or healthcare, attention to detail, and a clear understanding of regulatory requirements. Familiarity with pharmacovigilance databases, safety monitoring systems, and relevant certifications such as those from the Drug Information Association (DIA) or Regulatory Affairs Certification (RAC) is valuable. Strong analytical thinking, written communication skills, and the ability to work collaboratively across departments are valuable soft skills. These qualifications ensure accurate, reliable reporting and compliance with industry regulations, which is crucial for patient safety and effective risk management.

What are the typical challenges faced in an Adverse Event Reporting role?

Professionals in Adverse Event Reporting often handle large volumes of complex data that require careful evaluation and timely submission to regulatory authorities. One common challenge is staying up to date with ever-changing regulations and ensuring that all reports meet stringent compliance standards. Additionally, working across multiple teams—such as clinical, regulatory, and quality assurance—requires excellent coordination and communication skills. Being detail-oriented and proactive helps in identifying potential issues early and maintaining high-quality, compliant documentation.

What is an Adverse Event Reporting job?

An Adverse Event Reporting job involves monitoring, documenting, and reporting adverse events related to medical products, such as drugs, devices, or vaccines. Professionals in this role collect data from healthcare providers, patients, and clinical trials to ensure compliance with regulatory requirements. They analyze reports to assess potential safety concerns and work with regulatory agencies like the FDA or EMA. Their primary goal is to ensure patient safety by identifying and mitigating risks associated with medical products.

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Adverse Event Reporting jobs near you
Infographic showing various Adverse Event Reporting job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 67% In-person, and 33% Remote job distribution, with an average salary of $53,254 per year, or $25.6 per hour.
Manager, Quality - Adverse Event Reporting and Field Action

Manager, Quality - Adverse Event Reporting and Field Action

Terumo BCT, Inc.

Lakewood, CO

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted yesterday

Job description

Requisition ID:  34911  

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

The Adverse Event Reporting and Field Action Manager leads global vigilance and field action activities to ensure timely identification, evaluation, escalation, and reporting of adverse events and product performance issues for Terumo Blood and Cell Technologies (TBCT) medical devices. This role partners cross-functionally (Quality, Regulatory Affairs, Clinical/Medical, Engineering, Manufacturing, Supply Chain, Customer Support, and Legal) to drive compliant execution of reportability decisions, regulatory submissions, field safety corrective actions, and effectiveness checks, while strengthening systems, procedures, and metrics that support continuous improvement.

Essential Duties

  • Lead adverse event intake and triage: Oversee receipt, processing, and documentation of complaints and adverse event information from all sources; ensure data quality, completeness, and timely follow-up.
  • Case assessment and reportability: Drive consistent assessment of seriousness, expectedness (where applicable), causal relationship, and reportability across global jurisdictions; document rationales and maintain decision trees/guidance.
  • Regulatory reporting execution: Ensure accurate and timely submission of reportable events to applicable authorities (e.g., FDA MDR, EU vigilance, UK, Canada, Australia and other markets as applicable) and to customers/partners where required.
  • Field action leadership: Plan and manage field safety corrective actions (e.g., advisory notices, recalls, removals, corrections, software updates), including classification, strategy, communications, distribution controls, and closure.
  • Cross-functional investigation coordination: Partner with Global Complaint Handling, Global Medical Safety, Manufacturing Engineering, Quality Engineering, Risk Management and R&D to ensure thorough investigations, risk evaluations, and root cause analyses; ensure alignment between vigilance conclusions, CAPA, and risk management outputs.
  • Health hazard/risk evaluation: Coordinate health hazard evaluations and benefit-risk assessments supporting field action decisions and regulatory interactions; ensure traceability to risk management files.
  • Regulatory authority interaction: Serve as a primary point of contact for vigilance/field action communications with regulators; support inspections, audits, and requests for information.
  • Metrics and management review: Establish and report KPIs (timeliness, backlog, quality, recurrence, escalation, field action effectiveness); identify trends and drive improvements.
  • Process ownership: Own and maintain SOPs/work instructions for adverse event reporting, vigilance, and field actions; ensure alignment to applicable standards and regulations.
  • Systems oversight: Administer or provide process ownership for complaint handling/vigilance tools (e.g., eQMS modules); ensure proper configuration, validation, and user training in partnership with system owners.
  • Training and competency: Develop and deliver training to internal teams and affiliates on intake, documentation, escalation, reporting timelines, and field action execution.
  • Supplier and partner coordination: Manage vigilance interfaces with suppliers, contract manufacturers, distributors, and strategic partners; ensure clear quality agreements and timely data exchange.
  • Audit readiness: Maintain inspection-ready records, including case files, communications, decision rationales, submissions, and field action documentation.
  • People leadership (if applicable): Recruit, coach, and develop team members; set objectives, conduct performance management, and foster a culture of compliance and continuous improvement.
  • Perform additional related duties as assigned.
MINIMUM QUALIFICATION REQUIREMENT Education 
  • Bachelor's degree in Engineering, Life Sciences, Nursing, or related field, and/or equivalent combination of education and experience.
  • Master's degree or advanced clinical degree strongly preferred.

Experience

  • Minimum 7 years of experience in medical device post-market surveillance/vigilance, complaint handling, and/or regulatory compliance, including hands-on adverse event reporting responsibilities.
  • Minimum 3 years of experience leading field actions (recalls/corrections/removals) and cross-functional response teams.
  • Strong working knowledge of global vigilance and reporting requirements (e.g., FDA MDR 21 CFR Part 803, EU MDR vigilance, ISO 13485 complaint handling expectations, and applicable local-market requirements).
  • Demonstrated ability to interpret regulations and apply them to complex scenarios, strong documentation and technical writing skills.
  • Experience partnering with Quality/Risk Management and CAPA processes; ability to ensure traceability across complaint, investigation, risk, and CAPA records.
  • Proficiency with eQMS/complaint handling systems and Microsoft Office.
  • Strong communication, facilitation, and stakeholder management skills, including comfort interacting with regulatory authorities.
Preferred Qualifications
  • People management experience in a global vigilance or regulatory compliance organization.
  • Experience with blood management, apheresis, transfusion medicine, extracorporeal/sterile fluid path devices, or capital equipment with software and disposables.
  • Experience preparing health hazard evaluations, recall strategy documentation, and effectiveness checks across multiple regions.
  • Experience supporting FDA inspections and/or EU Notified Body audits related to PMS/vigilance and field actions.
  • Regulatory judgment and attention to detail
  • Risk-based decision making and sound escalation
  • Program/project management; ability to manage multiple priorities and deadlines
  • Clear, concise technical writing and documentation discipline
  • Influence without authority and cross-functional leadership
  • Data analysis, trending, and problem solving
  • Continuous improvement mindset

Certificates, Licenses, Registration

Certifications such as ASQ (CQA/CQE), RAC, or equivalent.

LOCATION

  • Lakewood, Colorado - Open to candidates willing to relocate to the area.
  • Office-based or hybrid work environment depending on business needs.

TRAVEL/HOURS

  • Travel required (up to 20%).
  • Domestic and international travel up to ~10-20% (may vary), including site visits, audits, and regulatory meetings.
  • May require occasional off-hours availability to support urgent safety issues and time-sensitive regulatory reporting.

PHYSICAL REQUIREMENTS

  • Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
  • The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. 
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:  $123,100.00 to $153,900.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  10.0%

We anticipate this requisition will be open for a minimum of five days, from April 6, 2026. We encourage your prompt application.

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
  • We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect - Appreciative of others
    • Integrity - Guided by our mission
    • Care - Empathetic to patients
    • Quality - Committed to excellence
    • Creativity - Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.

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