Safety Specialist Second

Summary

Join us today as a Safety Specialist II to improve the clinical research and development process for new therapeutics at Precision for Medicine.

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
• May participate in strategic department development initiatives
• Perform other duties as assigned

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation