Pharmacovigilance Associate
- Full-time
Job Description
Job Description
Shift: Monday to Friday, 10am-7pm or 11am-8pm
Mission
At Biologics by McKesson, our mission is to simplify access to medication and deliver personalized care that helps patients achieve the best-possible outcomes — one patient, one partner, one therapy at time.
Purpose
Pharmacovigilance is an important function of our patient management programs. Accurate and timely reporting of all adverse events to manufacturers is a key component of our Biopharma contracts.
Responsible for entering all adverse event information into the appropriate format for each manufacturer, quality assurance and timely submission of adverse event reports in accordance with company policies and biopharma client contracts.
Essential Duties and Responsibilities
- Creating and submitting adverse event and product complaint reports from data documented within our patient management system.
- Conduct quality check (QC) of information, spelling, drug, manufacturer and grammar included in the note.
- Communicating with clinicians regarding questions or concerns with the content or quality of adverse event reporting.
- Identify through the daily QC process and report any missing adverse events (AEs) and product complaints (PCs) to clinicians.
- Ensure that any identified missing reports have been submitted and accounted for.
- Maintain and submit weekly or monthly reconciliation reports to biopharma clients in accordance with client contracts.
- Assist clinical auditor in identifying trends or issues in adverse event reporting
- Perform other duties as assigned.
Qualifications
Minimum Qualifications
- 1+ years of related experience
Additional Qualifications
- Bachelor’s degree or commiserate experience preferred
- 1 year + experience working in a pharmacy setting preferred
- Oncology experience a plus
- Pharmacy technician or other clinical background preferred
- Excellent written and verbal communication skills
- Excellent organizational and time management skills
- Competent in moderate to advanced computer skills
- Competent in Excel spreadsheets
- Multi-task oriented
- Ability to effectively work with people
- Conscientious with excellent attention to detail
- Flexible and adaptable
- Essential to be able to type rapidly and accurately both numerical and text data
Career Level – IC – Operations Support – O2