BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Temporary Drug Safety Specialist to work for a leading San Diego biotechnology company.
Temporary Drug Safety Specialist
The Drug Safety Specialist will receive and analyze Serious Adverse Event (SAE) information for completeness, accuracy and regulatory requirements; evaluate SAE case data with an emphasis on medical presentation, conduct discussions regarding specific patient case data with CROs, Clients, and External Service Vendors; determine regulatory reporting requirements based upon case data, product information, and FDA or ICH guidelines and regulations; prepare SAE Reports, including preparation of narrative summary; identify missing/discrepant data, write queries, address queries with site personnel, evaluate query responses, and resolve queries when complete. Additionally, you will maintain the SAE database and perform coding of adverse event terms and concomitant medications.
Advanced understanding of applicable FDA, GCP, and ICH guidelines
Working knowledge of pharmacovigilance and clinical safety regulations and guidelines
Experience with coding dictionaries (knowledge of MedDRA and WHO Drug coding)
Experience with drug safety databases
Experience working in a team environment within cross-functional teams and in a fast-paced environment
Demonstrates initiative in identifying and solving problems
Demonstrates strong interpersonal and communication skills, resourcefulness, and personal organization skills
Strong database management skills and computer application skills including Microsoft Office
Experience using safety database software/safety applications is preferred
Knowledge of medical terminology and standard medical practices, and the ability to digest and apply new knowledge regarding disease entities as related to specific clinical trials
Ability to communicate clearly and precisely, both orally and in writing; ability to research information and prepare detailed written documents with attention to detail
A keen interest in medicine, pharmaceuticals, and regulatory affairs is essential for maintaining quality performance for this position, and continuing education in these areas is encouraged
Qualified candidates will have a Bachelor's degree in nursing (B.S.N.), or Registered Nurse (R.N.), and 3+ years' relevant experience. Requires in-depth knowledge of medical terminology and of GCPs, ICH guidelines and FDA regulations with an emphasis on safety. Must possess a professional demeanor; demonstrate initiative, sense of urgency, ability to organize and prioritize, and keen attention to detail.
BioPhase Solutions - 18 months ago