Medical Reviewer

Position Title: Medical Reviewer/Safety Reviewer II

Contract: 2 years (Remote)





Position Summary

We are seeking a clinically experienced professional to support clinical trial safety surveillance and medical data review for assigned studies. The role involves reviewing safety-related clinical data, identifying potential trends or concerns, supporting query resolution, and ensuring compliance with study protocols and applicable regulatory requirements.

The ideal candidate will have a health sciences background with clinical practice experience, strong critical-thinking skills, and exposure to
drug safety/pharmacovigilance and clinical trial data.





Key Responsibilities


- Perform timely review and assessment of clinical trial safety data, including
adverse events, laboratory results, vital signs, cardiac data, medications, and medical history.
- Conduct medical review of Case Report Forms (CRFs), safety listings, and related clinical data.
- Identify potential study-level safety trends and communicate relevant findings to the Study Lead and appropriate stakeholders.
- Review safety data for accuracy, quality, consistency, protocol compliance, and regulatory requirements.
- Monitor and support resolution of safety-related queries with investigators.
- Review and resolve clinical data queries and prepare addenda when required.
- Perform quality assurance reviews of safety data listings.
- Support adverse event investigation, assessment, documentation, and reporting activities.
- Provide medical/scientific support to Clinical, Medical Affairs, and Regulatory Affairs teams as required.
- Support preparation and review of study summaries, protocols, investigator brochures, and safety sections of regulatory documents.
- Provide safety-related training to internal teams and investigators, including CRF completion and serious adverse event reporting.
- Maintain awareness of applicable ICH, FDA, and EMA safety guidance and requirements.
- Manage assigned activities independently while adhering to departmental procedures, timelines, and quality standards.






Required Qualifications


- Bachelor's degree in Health Sciences, Nursing, Pharmacy, Life Sciences, or a related field.
- 2+ years of clinical practice experience required.
- Strong clinical knowledge and critical-thinking skills with the ability to assess adverse event and clinical trial data.
- Experience reviewing clinical data, CRFs, safety listings, or similar clinical documentation.
- Strong understanding of adverse event/serious adverse event data and safety reporting.
- Excellent written and verbal communication skills.
- Ability to identify and communicate medically relevant safety findings accurately.
- Proficiency with Microsoft Word, Excel, and standard computer applications.
- Ability to work independently with minimal supervision.






Preferred Qualifications


- 1+ year of Drug Safety / Pharmacovigilance experience.
- RN or clinical pharmacy background strongly preferred.
- Experience with clinical trials and safety surveillance.
- Experience with CRF review, query management, addenda, and data quality/QA activities.
- Knowledge of ICH, FDA, and EMA regulatory guidance related to clinical safety.
- Experience with adverse event investigation and reporting.
- Experience supporting regulatory submissions or safety documentation.
- Experience providing safety training to clinical teams or investigators.






Core Skills

Clinical Safety Review Drug Safety Pharmacovigilance Clinical Trial Data Adverse Events Serious Adverse Events CRF Review Query Resolution Safety Surveillance Medical Data Review ICH/FDA/EMA Clinical Practice Critical Thinking Data Quality Regulatory Compliance