Pharmacovigilance and Product Safety Specialist

Job Summary of the Pharmacovigilance and Product Safety Specialist

As a Pharmacovigilance and Product Safety Specialist, your role will be focused on the intake, investigation, evaluation, and healthcare provider consultation for reports of adverse effects (AE) of Axogen’s products. This role entails maintaining a vigilant, responsive, and professional relationship with our customers and their patients by acting as an effective communication steward in circumstances of untoward or adverse outcomes. Your responsibility will include conducting follow-up of adverse event reports from our field sales representatives or directly from healthcare professionals to create accurate records in the patient safety database by collecting information pertaining to: signs and symptoms, patient medical history, concomitant medications, and context of product administration. The Pharmacovigilance and Product Safety Specialist will perform the Medical Analysis for adverse event reports by evaluating the circumstances of adverse event reports associated with administration of Axogen’s products. This role will assist in the compilation and review of aggregate safety data and performance of signal detection activities by utilizing line listing reviews, case series reviews, disproportionality analysis, and other pharmacovigilance methods to understand and characterize the benefit-risk profile of Axogen’s products.

Requirements of the Pharmacovigilance and Product Safety Specialist

• A minimum of an R.N. with 3 years of related experience and/or training or an Advanced Degree in a Scientific Discipline required with at least 1 (one) of related experience and/or training.
• Working knowledge of anatomy and physiology and medical terminology in a healthcare setting required.
• Experience in writing patient safety narratives for individual case safety reports and medical coding using Medical Dictionary for Regulatory Activities (MedDRA) highly desired.
• Experience with patient safety databases (e.g. Oracle Argus; ArisGlobal) highly desired.
• Familiarity with HIPAA and understanding of FDA’s regulations and Guidance Documents for Drugs, Biologics, and Medical Devices is desired, but not required.
• Highly detail-oriented, well-organized, and diligent.
• Excellent oral and writing communication skills including the ability to interpret relevant details from intraoperative and clinic notes, histology and pathology reports.
• Good interpersonal skills with the ability to represent Axogen pharmacovigilance and patient safety in a positive and professional manner.
• Strong computer application skills used in general office settings including word processing, spreadsheets, presentation software, and Internet search engines.
• Excellent teamwork and collaboration.
• Good organizational and planning skills.
• Must display strong analytical and problem-solving skills.
• Attention to detail.

Responsibilities of the Pharmacovigilance and Product Safety Specialist

The specific duties of the Pharmacovigilance and Product Safety Specialist include but are not limited to:

Post-marketing Pharmacovigilance and Product Safety

• • Conducts follow-up of adverse event reports to collect missing information by conducting interviews with field sales personnel, nurses, surgeons, or other healthcare providers; obtains and collates intraoperative notes and histology/pathology reports.
  • Enters individual case safety report (ICSR) information e.g. patient demographic information, signs and symptoms, relevant medical history, concomitant medication into patient safety database; generates and reviews patient narratives.
  • Generates and reviews MedWatch, CIOMS I and CIOMS II reporting forms.
  • Responsible for completing Medical Analysis for adverse events reported with Axogen’s products e.g.
  • evaluating seriousness, expectedness, and causality for individual case safety reports (ICSR).
  • Representative on the Safety Management Committee as a medical subject matter expert (SME).
  • Contribute to the post-market signal detection program by assisting in the development of strategies and methods for continuous risk-benefit evaluation of Axogen’s products.

Clinical Research and Development Pharmacovigilance and Product Safety

• • Responsible for follow-up of potentially related adverse events reported from clinical trials.
  • Interacts with clinical research department for queries related to processing individual case safety reports from clinical trials.
  • Attend all appropriate Clinical Trial team meetings for initiated and on-going clinical trials; Safety Operations representative/member of all cross-functional team meetings.
  • Ensure that all relevant clinical safety data are collected in a timely manner and may assist in cleaning of data listings or provide support for data reconciliation.
  • Collaborate with Medical Advisors and Medical Officer to ensure adverse events from clinical trials are appropriately evaluated and entered in the safety database.

General Responsibilities

• • In coordination with the product safety teams, acts as a medical subject matter expert (SME), to collect and interpret relevant medical information for suspected adverse events reported with Axogen’s products.
  • Utilizes questionnaires and conducts interviews with field sales representatives, nurses, surgeons and other relevant healthcare professionals to follow-up on initial adverse event reports.
  • Completes Medical Analyses to characterize adverse events by evaluating the context of product administration, patient medical history, concomitant medications, patient signs and symptoms.
  • Contribute to the development of the signal detection program and maintenance of the Signal Detection Manual.
  • Interpret and apply the reference safety information (e.g. Company Core Data Sheet, Prescribing Information, Instructions for Use, Investigator’s Brochure, Risk Management Plan) in a practical manner when reviewing and evaluating adverse events.
  • Assists in the compilation and review of cumulative and interval patient safety data.
  • Assists in the facilitation and operation of the Safety Management Committees.
  • Triages adverse event reports received to the PV and Product Safety inbox.

Location

111 West Oak Ave., Tampa, FL  33602

Benefits/Compensation