Precision for Medicine is a precision medicine CRO. 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.
Due to our continued growth we are seeking a Safety Specialist who will be responsible for 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.
Essential functions of the job include but are not limited to:
- 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.
Qualifications:
Minimum Required:
- Life Sciences Degree or equivalent
- Minimum 3 years Clinical Trials Safety with Case Processing experience
- Oncology experience is essential
- Experience of managing multiple projects at one time
- 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
