Drug Safety Specialist II

Precision Medicine Group

Safety Specialist II managing serious adverse event cases and collaborating with sponsors at Precision Medicine Group. Ensuring quality safety data management and regulatory compliance in a remote role.

Posted 7/6/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $75,600 - $113,400 per yearWebsite

About the role

Key responsibilities & impact

Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel.
Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems.
Participate in the assessment and set-up of a safety database to capture SAE data.
Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures.
QC of documents and safety reports.
Preparation and/or review of project-specific safety reporting plans and medical coding plans.
Preparation and/or review of safety training materials.
Provide safety training and oversight for consultants, contractors and/or staff.
Review and/or draft standard operating procedures and work instructions.
Assist clients and/or other departmental staff with safety-related reviews and other services.
Other duties as assigned.

Requirements

What you’ll need

BA/BS degree
Minimum 2 years safety experience
Health care professional
Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation
Working knowledge of MedDRA and WHODrug
Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations.
Nursing or pharmacy degree preferred
Clinical trial safety experience
Hands on experience with Argus
Industry experience in CRO or pharmaceutical company preferred

Benefits

Comp & perks

Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Discretionary annual bonus

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Data EntryMedical CodingNarrative WritingSafety Report GenerationQC of DocumentsSafety Database AssessmentSafety Training PreparationStandard Operating Procedures ReviewExpectedness AssessmentIndividual Case Safety Reports (ICSRs)

Soft Skills

Interpersonal CommunicationTeam CollaborationTraining and Oversight