Job Description
Pay range: 61-64/hr
*depending on experience
DRUG SAFETY SPECIALIST
POSITION SUMMARY:
The Drug Safety Specialist is primarily responsible for case processing of serious adverse events, serious and non-serious adverse drug reactions and other medically related project information such as adverse events of special interest and product complaints.
This position is fully remote.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Reviews, processes, and assesses adverse event reports (AERs) from clinical trials and post-marketing sources
· Enters and maintains safety data in the global safety database
· Prepares and submits safety reports to regulatory authorities in accordance with global safety reporting requirements
· Performs QC of cases to ensure quality levels are maintained per DOB’s expectations
· Manages the safety intake mailbox including the triage of incoming reports for completeness, legibility, and validity
· Query management
· Maintains electronic documentation for case files within the safety database
· Assists with reconciliation of the safety and clinical trial databases
· Collaborates with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory agencies
· Adheres to all relevant pharmacovigilance regulations and company policies
· Assists in development of project-specific safety procedures, workflows, and templates.
· Assists in project-specific safety database setup, management of data entry guidelines, and user acceptance testing.
· MedDRA and WHODrug coding in the safety database
· Preparation for, participation in, and follow-up on audits and inspections
· Provides training and guidance to colleagues on drug safety processes and procedures.
· Stays updated on industry developments and changes in drug safety regulations.
· Maintains confidentiality and adheres to ethical standards in handling sensitive and confidential information.
· Performs other duties and responsibilities as assigned by management.
QUALIFICATIONS
· Degree in Pharmacy, Nursing, Life Science, or other fields, or equivalent qualification/work experience
· The ideal candidate will have 2+ years of recent case processing experience and must include experience processing post-marketing cases
· MedDRA and WHODrug coding experience
· Must be fluent in English with excellent written and verbal communication skills
· Detail orientated and capable of working effectively within a team environment.
· Excellent organizational and prioritization skills
· Analytical and problem-solving skills
· Able to perform database/literature searches
· Experience working in RxLogix’s Pharmacovigilance Case Management system a plus
Job Tags
Contract work, Work experience placement,