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Clinical Safety Reviewer Jobs (NOW HIRING)

Lumicell

Clinical Safety Specialist

Waltham, MA · On-site

The Clinical Safety Specialist is a key operational role responsible for the day-to-day management ... Coordinate internal post-market safety and medical review meetings; prepare, quality-check, and ...

Lumicell

Clinical Safety Specialist

Waltham, MA

The Clinical Safety Specialist is a key operational role responsible for the day-to-day management ... Coordinate internal post-market safety and medical review meetings; prepare, quality-check, and ...

Lumicell

Clinical Safety Specialist

Waltham, MA · On-site

The Clinical Safety Specialist is a key operational role responsible for the day-to-day management ... Coordinate internal post-market safety and medical review meetings; prepare, quality-check, and ...

JenaValve

Specialist, Clinical Safety

Irvine, CA · On-site

$100K/yr

Review and analyze aggregate safety reports to identify early safety signals; escalate findings to ... Provide clinical and medical subject matter expertise to address safety-related questions from ...

Medpace, Inc.

Clinical Safety Manager

Cincinnati, OH · On-site

Provide safety review of clinical study documents, including protocols, study reports; and marketing application components Qualifications * BSN or equivalent healthcare experience with a bachelor ...

Medpace, Inc.

Clinical Safety Manager

Cincinnati, OH

Provide safety review of clinical study documents, including protocols, study reports; and marketing application components Qualifications * BSN or equivalent healthcare experience with a bachelor ...

Medpace, Inc.

Clinical Safety Manager

Cincinnati, OH

Provide safety review of clinical study documents, including protocols, study reports; and marketing application components Qualifications * BSN or equivalent healthcare experience with a bachelor ...

Medpace, Inc.

Clinical Safety Nurse

Cincinnati, OH · On-site

Job Summary We are currently seeking a full-time, office-based Clinical Safety Nurse to join our ... review your qualifications and, if interested, you will be contacted with details for next steps.

Medpace, Inc.

Clinical Safety Nurse

Cincinnati, OH · On-site

Job Summary We are currently seeking a full-time, office-based Clinical Safety Nurse to join our ... review your qualifications and, if interested, you will be contacted with details for next steps.

Gilead

Director, Nonclinical Safety

Foster City, CA · On-site

$226K - $292K/yr

Serves as a nonclinical safety development resource, working with other members of the department ... Reviews protocols, data and study reports ensuring presentation of data in report is accurate and ...

Gilead

Director, Nonclinical Safety

Foster City, CA · On-site

$226K - $292K/yr

Serves as a nonclinical safety development resource, working with other members of the department ... Reviews protocols, data and study reports ensuring presentation of data in report is accurate and ...

MicroVention

Specialist, Clinical Safety (US Remote)

$105K - $131K/yr

Draft, review, and provide input to the clinical safety components of clinical study protocols, study reports, safety manuals, safety CRFs, study supporting materials, and other related documentation.

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Clinical Safety Reviewer information

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How much do clinical safety reviewer jobs pay per hour?

As of Jul 17, 2026, the average hourly pay for clinical safety reviewer in the United States is $35.92, according to ZipRecruiter salary data. Most workers in this role earn between $31.25 and $40.38 per hour, depending on experience, location, and employer.

What are Clinical Safety Reviewers?

Clinical Safety Reviewers are professionals responsible for evaluating and monitoring the safety of pharmaceutical products and medical devices during clinical trials. They review clinical data to identify potential safety concerns, assess adverse event reports, and ensure that all regulatory requirements regarding patient safety are met. Clinical Safety Reviewers collaborate with medical teams, regulatory agencies, and other stakeholders to ensure the safety and well-being of trial participants. Their work is crucial in minimizing risks and ensuring that treatments are safe before they reach the market.

How does a Clinical Safety Reviewer typically collaborate with other teams during the drug development process?

Clinical Safety Reviewers work closely with cross-functional teams such as clinical operations, data management, medical monitors, and regulatory affairs. They regularly communicate findings from safety data analyses, contribute to safety review meetings, and provide input for safety sections in regulatory submissions. This collaborative approach ensures that safety signals are identified early and managed appropriately, supporting both patient wellbeing and project timelines. Strong teamwork and clear communication are essential for success in this role.

What is the difference between Clinical Safety Reviewer vs Pharmacovigilance Associate?

AspectClinical Safety ReviewerPharmacovigilance Associate
Required CredentialsBachelor's degree, life sciences background, possibly certification in drug safetyBachelor's degree, life sciences background, often entry-level
Work EnvironmentPharmaceutical companies, CROs, clinical trial settingsPharmaceutical companies, CROs, regulatory agencies
Employer & Industry UsageFocuses on safety data review during clinical trials and post-marketingSupports safety data processing, case entry, and reporting
Common Search & Comparison IntentUnderstanding safety review roles in clinical trialsEntry-level safety data support roles

The Clinical Safety Reviewer primarily evaluates safety data during clinical trials and post-marketing, requiring specialized safety knowledge. In contrast, the Pharmacovigilance Associate handles data entry, case processing, and supports safety reporting. Both roles are essential in drug safety but differ in responsibilities and experience levels.

What are the key skills and qualifications needed to thrive as a Clinical Safety Reviewer, and why are they important?

To thrive as a Clinical Safety Reviewer, you need a strong background in life sciences or pharmacy, experience in pharmacovigilance, and knowledge of regulatory requirements such as ICH guidelines. Familiarity with safety databases (like Argus or ArisGlobal), MedDRA coding, and case processing systems is typically required. Attention to detail, critical thinking, and effective communication are standout soft skills in this role. These capabilities ensure accurate safety assessment, regulatory compliance, and the protection of patient well-being in clinical trials.
More about Clinical Safety Reviewer jobs
What job categories do people searching Clinical Safety Reviewer jobs look for? The top searched job categories for Clinical Safety Reviewer jobs are:
Clinical Safety Reviewer jobs near you
Infographic showing various Clinical Safety Reviewer job openings in the United States as of July 2026, with employment types broken down into 3% As Needed, 72% Full Time, 18% Part Time, and 7% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $74,707 per year, or $35.9 per hour.
Clinical Safety Specialist

Clinical Safety Specialist

Lumicell

Waltham, MA • On-site

Full-time

Re-posted 4 days ago

Job description

About Us
At Lumicell, we'll give you the opportunity to harness all that's within you by working in a mission-driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. You will be a part of something groundbreaking as we expand our commercial launch and continue investigations in other cancer indications.
The Clinical Safety Specialist is a key operational role responsible for the day-to-day management and oversight of post-market safety activities for a commercial medical devices/fluorescent drug combination product, with supporting responsibilities for investigational device/drug safety. This position serves as the primary owner of third-party pharmacovigilance vendor oversight, coordinates internal medical and safety review processes, manages the Clinical Endpoint Adjudication Committee (CEAC) for a large prospective post-market safety study, contributes to clinical operations and tasks associated with safety data collection for clinical studies, and supports the accurate integration and reconciliation of safety data across post-market and clinical safety systems. This role requires a high level of attention to detail, strong process discipline, and the ability to manage complex safety workflows where data accuracy, traceability, and regulatory compliance are critical. We are looking for a self-starting and collaborative team member.
What you will do:
  • Serve as the operational lead for post-market pharmacovigilance and safety surveillance activities for commercial combination product.
  • Ensure post-market adverse events are collected, tracked, assessed, and documented in accordance with internal SOPs, applicable regulations, and post-market safety plans.
  • Act as primary point of contact and operational owner for third-party Pharmacovigilance Service Providers (PVSPs), including oversight of case processing quality, regulatory reporting timelines, and compliance with Client Working Processes and Statements of Work.
  • Coordinate internal post-market safety and medical review meetings; prepare, quality-check, and distribute safety review materials; and document decisions, rationales, and action items with clear traceability.
  • Manage all operational aspects of the Clinical Endpoint Adjudication Committee (CEAC), including member onboarding, training, logistics, adjudication packet preparation, meeting coordination, and documentation of adjudication outcomes.
  • Ensure adjudicated endpoints and safety outcomes are accurately captured, reconciled, and reflected in post-market safety datasets, clinical databases, and downstream analyses and reports.
  • Support clinical study operations associated with post-market safety studies, including coordination with Clinical Operations and Data Management on safety data collection, query resolution, and protocol- and SAP-aligned safety endpoints.
  • Serve as a safety operations liaison for post-market safety studies, supporting study start-up, ongoing execution, and close-out activities related to safety data workflows.
  • Act as primary point of contact for third party central laboratory receiving and processing samples to support safety evaluations, overseeing contracting and adherence to lab manual processes
  • Maintain highly detailed, audit- and inspection-ready documentation for vendor oversight, CEAC operations, safety reviews, and clinical study safety support activities.
  • Contribute to continuous improvement of post-market safety and clinical safety workflows, templates, and tracking tools, with a strong emphasis on data accuracy, consistency, and attention to detail.
  • Support FDA inspections, audits, and regulatory inquiries related to post-market safety surveillance, clinical safety oversight, and endpoint adjudication.
  • Work closely with Medical, Monitor, Clinical Operations, Data Management

Regulatory & Standards Framework
Activities performed in this role are conducted in alignment with applicable regulatory requirements and recognized standards, including:
  • 21 CFR Part 4 - Combination Products
  • 21 CFR Part 803 - Medical Device Reporting (MDR)
  • 21 CFR Part 812 - Investigational Device Exemptions (as applicable)
  • 21 CFR Part 312 - Investigational New Drug Applications (as applicable)
  • FDA-mandated post-market surveillance and post-approval study requirements, including Section 522 studies and PMRs/PMCs, as applicable
  • ISO 14971 - Application of risk management to medical devices
  • Applicable principles of ICH E6 (Good Clinical Practice)
  • Applicable principles of ICH E2 for safety data collection and reporting

What you will bring:
  • Bachelor's degree in life sciences, nursing, pharmacy, public health, or a related discipline.
  • 3-5+ years of experience in post-market safety, pharmacovigilance, medical device surveillance, drug safety or clinical safety operations.
  • Demonstrated experience managing or overseeing third-party pharmacovigilance vendors.
  • Exceptional attention to detail, with a demonstrated ability to manage complex safety data, track issues across systems, and maintain accurate, auditable documentation.
  • Strong written and verbal communication skills, with demonstrated ability to document safety assessments and decisions clearly and precisely.
  • Demonstrated ability to manage multiple tasks, prioritize deliverables, anticipate challenges, and execute on goals as a member of an interdisciplinary team.

An outstanding candidate will also possess the below experience:
  • Advanced degree (MS, MPH, PharmD, RN, or equivalent).
  • Experience with large prospective post-market safety studies, registries, or post-approval studies.
  • Familiarity with clinical trial systems (EDC, CTMS) and safety databases, including safety data reconciliation activities.
  • Prior experience supporting FDA inspections or audits related to post-market safety or pharmacovigilance.

Position Type/Expected Hours of Work:
  • This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
  • This is a Hybrid position, and the ability to be on-site 3 days a week is required.

Lumicell is committed to a diverse and inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.
Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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