Responsible for receiving and processing AEs reported to Luitpold Pharmaceuticals, Inc. from any internal or external source of any product sold or distributed by the company and its divisions.
Interact with Medical Monitors, Project Managers, CRAs, Project Coordinators, external clinical site investigators, nurses, pharmacists, patients, and outside corporate manufacturing partners/distributors in order to receive, follow-up and report AEs according to company SOPs.
Work with individuals in each division and across various departments (regulatory, clinical R&D, professional services, and quality assurance) interfaced with the Pharmacovigilance process.
Coordinate investigations with Quality Assurance (QA) Department (Shirley, NY).
Provide input into SOPs, updates, and modifications to initiate appropriate changes.
Provide input on end-users’ issues with safety database (PV-Works).
Review of study safety tables and listings
Generate Periodic (Quarterly and Annual) Reports relating to Pharmacovigilance with regulatory.
Supervise intake of AEs, making certain all required elements of a safety report are captured and that FDA guidelines are followed.
Enter data and track reports via PV Works and SAE reports.
Prepare SAE narratives, and collaborate with CROs for SAE reconciliation.
Review and verify AE and concomitant medication coding via MedDRA and WHO Drug coding internally and with CROs.
Identify safety signals and coordinate with Director of Pharmacovigilance and Medical Directors as to their interpretation.
Generate IND Safety Reports following FDA guidelines
Clinical Degree (RN, LPN, BSN, RPh, PharmD)
5 years PV reporting experience
Excellent written and verbal skills
Knowledge of FDA regulations for industry governing reporting of adverse drug experiences.
Knowledge/experience with the handling of adverse drug experiences
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.