Safety Specialist/Safety Lead

Precision Medicine Group; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Precision Medicine Group is seeking a Safety Specialist/Safety Lead to join our clinical safety team. You will develop safety management plans, manage SAE/SUSAR case processing, and provide safety expertise to study teams, clients, and site personnel.

Responsibilities include safety database setup, safety reporting planning, training material development, and collaboration with sponsors and vendors to ensure regulatory compliance and timely safety submissions.

Qualifications

• BA/BS degree required in healthcare or related field.
• Minimum 5 years safety experience in clinical research or pharma.
• Hands-on experience with global safety databases and SAE case processing.

Responsibilities

• Develop safety management plans and oversee SAE/SUSAR processing.
• Provide safety expertise to team members, clients, and site personnel.
• Interface with sponsors and vendors to design safety collection tools and reporting.
• Set up and maintain safety databases and safety reporting plans.
• Review safety documents and training materials; provide training as needed.
• Assist with safety reviews and other departmental services.
• Other duties as assigned.

Skills

Safety management

SAE processing

Regulatory reporting

FDA regulations

ICH guidelines

Global safety regulations

Education

BA/BS degree

Nursing or Pharmacy degree preferred

Tools

Argus

MedDRA

WHODrug

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

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

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].