Position Overview
Ensures that all adverse event reports received by Clinquest, Inc. are assessed for reportability; evaluates safety data and alerts managers as necessary. Familiar with standard Pharmacovigilance case processing and database packages. Participates in cross functional project teams. Participates in the preparation of regulatory reports including but not limited to CSRs, INDs and PSURs.
Duties/Responsibilities
- Assesses reports for serious criteria according to applicable SOP, ICH, and Federal Regulations
- Maintains currency with standards, client specific SOPs, work instructions, and position specific training, and regulations
- Monitors and processes case information in accordance with Federal Regulations
- Determines whether data received is a SAE or AE and processes according to Federally mandated guidelines
- Researches information and composes narratives for case reports
- Orders and reviews articles to rule out or validate AE
- Prepares case reports for medical review
- Assesses case reports for due diligence
- Acts as case owner for assigned case reports
- Ensures SAE reconciliations between Safety and Clinical data bases
- Responsible for due diligence; i.e., sending medical information requests
- Routinely assesses and analyzes medical information to determine course of action
- Participates as a subject matter expert representing Pharmacovigilance including but not limited to product coding and product review meetings
- Trains new Pharmacovigilance team members
- Performs other duties as assigned by Clinquest
- Performs other duties as assigned by client
Position Qualifications
- Bachelor’s degree in health care related field or sciences
- 3 or more years in drug safety or related field
- 1 or more years case processing experience
- Subject matter expert in Pharmacovigilance
- Consistently required to use independent judgment
- Excellent written and verbal communication skills
- Detail-oriented with excellent organizational skills
Other Skills/Abilities
- Proficiency in standard word processing, spreadsheet, and database packages
- Knowledge of medical terminology and coding dictionaries
- Use of critical thinking and strong analytical skills required for problem solving
- Consistently demonstrates leadership capacity