Remote Pharmacovigilance Operations Specialist RN/NP/PA
- Clinical License RN, ARNP/APRN, PA-C
- State(s) Nationwide
$25 – $32 an hour
Full Job Description
- Degree in a scientific or healthcare discipline (such as Nurse, MD, Pharmacist, or PharmD or other healthcare disciplines) ideally with 4+ years’ similar experience or an equivalent combination of education, training and experience.
- Experience in Lifecycle safety (Pharmacovigilance, Medical Information, Aggregate Reporting, Risk Management etc.)
- Experience in Therapeutic areas – Rare disease, infectious disease, oncology, etc.
- Creating Adverse Event and Product Quality Complaint reports requiring concise data entry covering everything from patient symptoms, admission and results – this will include medical terminology, writing narratives, generating case queries.
- Clarify, investigate and capture adverse event and product quality information
Receive, triage, review and process data from various sources on time, within budget and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of primary review.
- Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting.
- Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
- Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
Job Types: Full-time, Contract
Pay: $25.00 – $32.00 per hour
- Monday to Friday
- Doctorate (Required)
- Drug or Lifecycle Safety: 2 years (Preferred)
- Fully Remote