BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Drug Safety Associate to work for a leading San Diego biotechnology company.
Drug Safety Associate - San Diego Candidates only, please
The Drug Safety Associate is responsible for overseeing specific aspects of adverse event processing and reporting for assigned investigational and marketed products. This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
DUTIES & RESPONSIBILITIES:
Conducts complete clinical reviews of all domestic and foreign adverse event reports for all investigational and marketed products
Ensures consistency in the initial evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility
Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet.
Ensures timely submission of expedited reports according to US FDA regulations
Performs database reconciliation in collaboration with Data Management
Develops, maintains and ensures documentation of drug safety and pharmacovigilance processes and procedures
Co-authors annual reports and periodic safety reports
Maintains SOPs, working guidelines and conventions
Ensures compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements
Interacts on a regular basis with safety colleagues to identify process improvement strategies and communicate project status updates
Interacts on a regular basis with contract drug safety vendor(s) (case processing, call center, etc.) to resolve safety-related issues.
Performs all duties in keeping with the Companyâ€™s core values, policies and all applicable regulations.
EDUCATION / EXPERIENCE:
A BA/BS degree preferred or equivalent in pharmacy, nursing or life sciences
At least 2-5 years of clinical safety and/or pharmacovigilance experience or equivalent
Familiarity with safety databases, data entry platforms, adverse event data collection process, case processing, call center, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements, post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, and Regulatory Approval Process
General understanding of the drug development process