Remote Medical Safety Specialist II/III

Actalent; United States; Remote; USD 62,000 - 75,000; Part time

Job summary

Actalent is seeking a Medical Safety Specialist II/III for remote work in the United States to support ongoing safety surveillance and regulatory communications. You will review clinical trial data, monitor adverse events, and collaborate with Medical Affairs and Clinical teams to ensure data accuracy and regulatory compliance.

The role requires RN licensure, clinical/pharmacy background, and 2+ years of patient-care or drug safety experience, with strong analytical and communication skills.

Qualifications

• Bachelor's degree in a health science discipline.
• Active RN license required.
• Clinical practice experience preferred.
• 1 year of drug safety experience preferred.
• Ability to present medical data clearly and accurately.
• Experience with adverse event reporting and data documentation.

Responsibilities

• Provide timely medical assessment of reported clinical trial data.
• Review safety data including lab results, vital signs, and medical history.
• Perform detailed safety data reviews for regulatory compliance.
• Respond to safety-related queries from investigators and teams.
• Conduct in-house medical review of CRFs and data listings.
• Organize files and budgets for multiple studies.
• Support regional CRAs to ensure data quality and protocol adherence.
• Provide medical support for adverse event reporting and investigations.
• Prepare adverse event documentation for regulatory authorities (e.g., FDA).
• Draft responses to medical/information requests from professionals and lay audiences.
• Deliver training on safety topics and SAE reporting.
• Write study summaries, protocols, IBs, and IND updates for safety data verification.

Skills

RN license

Clinical experience

Drug safety

Adverse event data review

Medical communication

Regulatory knowledge

Strong written/verbal communication

Regulatory adherence

Education

Bachelor's degree in health science

Active Registered Nurse (RN) license

PharmD or clinical pharmacy background

Tools

Windows OS

Microsoft Word

Microsoft Excel

Job description

Actalent is seeking a Medical Safety Specialist II/III for remote work in the United States to support ongoing safety surveillance and regulatory communications. You will review clinical trial data, monitor adverse events, and collaborate with Medical Affairs and Clinical teams to ensure data accuracy and regulatory compliance.

The role requires RN licensure, clinical/pharmacy background, and 2+ years of patient-care or drug safety experience, with strong analytical and communication skills.