Safety Specialist Second
pfm medical, inc.
π΅ $72k-$108k
πRemote - United States
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Job highlights
Summary
Join us today as a Safety Specialist II to improve the clinical research and development process for new therapeutics.
Requirements
- 4-year college degree, or equivalent experience ideally in Pharmacy, Nursing, scientific or healthcare discipline
- 3-5 years clinical trial, PV/Drug Safety experience
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Health care professional (i.e., RN, BSN, MD, PharmD)
- Hands on experience with global safety database(s), SAE case processing including narrative writing, and safety reports generation
- Proficient MedDRA and WHO Drug coding
Responsibilities
- Process, evaluate, and report incoming Serious Adverse Event (SAE) reports according to applicable regulatory guidelines/requirements
- Serve as primary safety specialist on complex studies, applying and providing guidance and safety expertise to clients and team members
- Interface with sponsors, vendors, and other internal team members related to drug 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)
- Prepare and/or review project-specific safety reporting plans and medical coding plans
- Prepare and/or review safety training materials
- Review and/or draft standard operating procedures and work instructions
- Mentor or train new PV staff
Benefits
- Health insurance
- Retirement savings benefits
- Life insurance and disability benefits
- Parental leave
- Paid time off for sick leave and vacation
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