Pharmacovigilance Associate

Position Title: Pharmacovigilance Associate

Work Location: Candidate must be local to Cary, NC (within a 60-mile radius)

Assignment Duration: 5 Months

Work Schedule: 9:00am-6:00pm eastern or 10:00am-7:00pm eastern

Work Arrangement: Remote: 1 week of onsite onboarding at Cary, NC, then 1 week of one-on-one training with Lead onsite. Then fully remote afterwards.

Position Summary:

Creating and submitting adverse event and product complaint reports from data documented within our patient management system.

Key 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

Qualification & Experience:

* Bachelor's degree or commensurate experience preferred

* Prior experience working in a Pharmacy setting preferred

* Oncology experience a plus

* Pharmacy technician or other clinical background preferred

* Prior experience with pharmacovigilance strongly 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.