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 [email protected].
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Skills Required
- BA or BS degree
- At least 5 years of safety experience
- Healthcare professional background
- Hands-on experience with global safety databases
- Experience processing serious adverse event cases, including narrative writing and safety report generation
- Working knowledge of MedDRA and WHODrug
- Working knowledge of FDA safety regulations, ICH guidelines, and global safety regulations
- Nursing or pharmacy degree
- Clinical trial safety experience
- Hands-on experience with Argus
- Industry experience in a CRO or pharmaceutical company
Precision Medicine Group Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Precision Medicine Group and has not been reviewed or approved by Precision Medicine Group.
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Healthcare Strength — Health coverage includes medical, dental, and vision with HSA/FSA options, plus disability and life insurance, forming a comprehensive core package. The lineup is presented as robust across wellbeing, time off, and financial security categories.
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Leave & Time Off Breadth — Time off includes generous PTO and paid holidays, along with paid parental leave and adoption assistance. These offerings are positioned as part of a well-rounded benefits suite in the U.S. with similar cores noted in Canada.
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Retirement Support — Retirement programs include a 401(k) with employer match in the U.S. and a group retirement plan in Canada. These elements help establish a competitive total rewards foundation.
Precision Medicine Group Insights
What We Do
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.
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