Safety Specialist/Safety Lead

Pfm; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Precision Medicine Group is seeking a Safety Specialist/Safety Lead to join our expanding team in the United States. The role focuses on safety management, SAE/SUSAR case processing, and timely regulatory reporting, with collaboration across sponsors, vendors, and study sites.

Ideal candidates will have a BA/BS degree, at least 5 years of safety experience, and hands-on experience with global safety databases, MedDRA/WHODrug, and FDA/ICH regulations.

Qualifications

• BA/BS degree.
• Minimum 5 years safety experience.
• Health care professional.
• Hands on experience with global safety databases, 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.

Responsibilities

• Develop safety management plans and ensure regulatory compliant reporting.
• Manage SAE/SUSAR case intake, processing, and narrative generation.
• Provide safety expertise to team members, clients and site personnel.
• Interface with sponsors and internal teams to design safety tools and reporting systems.
• Assist in setting up a safety database and data capture of SAE data.
• QC safety documents and safety reports.
• Prepare and review safety reporting plans and medical coding plans.
• Prepare and review safety training materials and deliver oversight.

Skills

SAE case processing

Regulatory reporting

MedDRA knowledge

FDA regulations

Education

BA/BS degree

Tools

Argus

Job description

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

As our company continues we grow we are seeking a Safety Specialist/Safety Lead to join our growing team.

Position Summary

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.

Essential functions of the job include but are not limited to:

• 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.

Requirement:

• BA/BS degree
• Minimum 5 years safety experience

Other Required:

• 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.

Preferred:

• Nursing or pharmacy degree preferred
• Clinical trial safety experience
• Hands on experience with Argus
• Industry experience in CRO or pharmaceutical company preferred

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].