Job Description

Medical Safety Specialist II / III

The Medical Safety Specialist plays a key role in clinical trial safety surveillance by performing timely medical review of trial data, identifying potential safety trends, and ensuring adherence to regulatory guidance and study protocols. This role focuses on the assessment and interpretation of safety-related data, including adverse events, and supports cross-functional teams with medically sound analyses and documentation. The position is remote and involves close collaboration with study leads, investigators, and internal stakeholders to maintain high-quality safety oversight throughout the lifecycle of assigned clinical studies.

Responsibilities:

• Provide timely medical assessment of reported clinical trial data and actively participate in safety surveillance activities for assigned studies.
• Review clinical trial data including laboratory results, vital signs, cardiac assessments, concomitant medications, and medical history, and communicate relevant safety findings to the Study Lead.
• Perform detailed review of safety-related data from clinical trials for content, quality, potential study-level trend identification, and adherence to regulatory guidance and study protocols using strong critical thinking skills.
• Monitor and respond to safety-related queries directed to investigators, ensuring clear, accurate, and timely resolution.
• Conduct in-house medical review of Case Report Forms (CRFs), including query resolution, preparation of addenda, and quality assurance of data listings.
• Organize files and budgets associated with multiple clinical studies, supporting efficient study management and documentation.
• Support and, where applicable, manage activities of regional contract Clinical Research Associates (CRAs) to help maintain data quality and protocol compliance.
• Provide medical support for adverse event reporting, including investigation and documentation of medical product experiences and in-depth analysis of medical adverse events.
• Collaborate with Medical Affairs, Clinical, and Regulatory Affairs teams in preparing adverse event documentation for regulatory authorities such as the FDA.
• Contribute to medical communication activities by writing standard and customized responses to medical and scientific information requests from healthcare professionals and the lay community.
• Respond to complex inquiries that require detailed medical and scientific information beyond package inserts or standard letter databases, including appropriate handling of off-label information.
• Deliver training on safety-related topics internally and at investigator meetings, including guidance on serious adverse event reporting and CRF completion.
• Write study summaries and review protocols, investigator brochures, and IND annual updates to verify and ensure accuracy of safety data.
• Adhere to ICH, FDA, EMA regulatory guidance, departmental processes, and internal policies with minimal supervision, maintaining current knowledge of evolving safety surveillance standards.
• Present accurate and medically sound safety data, both orally and in writing, to internal and external stakeholders as needed.

Essential Skills:

• Bachelor's degree in a related health science discipline.
• Active Registered Nurse (RN) license.
• Minimum of 2 years of bedside clinical practice experience.
• Clinical pharmacy or PharmD background with hospital-based experience strongly preferred.
• At least 1 year of drug safety experience preferred.
• Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and data assessment.
• Proven ability to present accurate and medically sound safety data in both written and verbal formats.
• Effective communication skills for delivering study-related information to investigators and internal teams.
• Proficiency with Windows operating systems and Microsoft Word and Excel.
• Demonstrated experience in medical review of clinical data, including CRFs and adverse event information.
• Ability to work with minimal supervision while following regulatory guidance, protocols, and departmental processes.
• Experience in hospital or clinical environments with direct patient care responsibilities.

Additional Skills & Qualifications:

• RN or clinical pharmacy experience is strongly preferred.
• PharmD with hospital-based experience is highly desirable.
• Candidates with overseas clinical experience who are seeking to gain experience in the U.S. are welcome.
• Any additional clinical experience beyond the minimum requirements is considered a plus.
• Familiarity with ICH, FDA, and EMA regulatory guidance related to safety surveillance.
• Experience in drug safety, pharmacovigilance, or clinical research environments.
• Comfort working with data listings, queries, and documentation for clinical trials.
• Ability to contribute to medical communication, including drafting standard and customized responses to medical inquiries.
• Experience providing training on safety issues, serious adverse event reporting, and CRF completion.
• Capability to support review of protocols, investigator brochures, and IND annual updates for safety data verification.

Work Environment:

This is a remote position that supports multiple clinical studies in a structured, compliance-focused environment. You will work extensively with electronic clinical trial data, Case Report Forms, and safety documentation, using standard office technology such as Windows-based computers and Microsoft Word and Excel. Collaboration occurs virtually with study leads, investigators, and cross-functional teams in Medical Affairs, Clinical, and Regulatory Affairs. The role involves detailed analytical work, documentation, and communication within a professional setting that emphasizes regulatory adherence, data quality, and patient safety. Working hours follow typical business patterns, with flexibility aligned to study needs and global collaboration requirements.

Job Type & Location:

This is a Contract position based out of Remote, OR.

Pay and Benefits:

The pay range for this position is $30.00 - $36.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully remote position.

Application Deadline:

This position is anticipated to close on Sep 29, 2026.

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