| Job Description | Overview
The Pharmacovigilance Associate will be supporting and assisting in handling of safety information originating from clinical trials. This person will assist with managing the safety tasks performed by a safety provider and will focus on efficient, accurate and timely reporting of adverse events and support PV managers with applicable safety activities. This person will also play an important role representing Pharmacovigilance group during daily interactions with clinical, scientific and regulatory groups at Pearl.
Description of Duties
Serve as primary role for triage and quality control (QC) of individual case safety reports (ICSR) ensuring that cases are reviewed and completed in a timely manner in accordance with appropriate SOPs (standard operating procedures), study protocols and regulatory guidelines
Prepare and review queries to obtain critical or missing serious adverse events (SAE) information for appropriate medical assessment and case closure
Serve as Adjudication Coordinator and ensure that endpoint dossiers are prepared and completed in timely manner for submission to Adjudication Committee
Participate in preparation and drafting of ad-hoc and aggregate regulatory reports (IND/DSUR) and labeling support documents
Ensures compliance with health authority regulations in all aspects of PV case processing and reporting
Contributes to regulatory responses, Investigators Brochure (IBs), study protocols, case report form (CRFs), Reports, and other documents as required
Collaborates with team members on the development and implementation of PV standard operating procedures (SOPs) and working processes (WPDs)
Manages electronic and hard copy document management, retrieval, and archiving of PV information including ICSRs
Reviews and reconciles SAE data between clinical and safety databases
Assist with data-lock reconciliations and ensure all cases are complete and all outstanding queries are resolved and closed
Liaise with clinical operations, regulatory affairs, clinical research organization (CRO) and data management groups regarding safety data collection and data reconciliation
Remains informed of all appropriate current health authority regulations and guidance
Minimum Requirements
Education/Experience:
The Pharmacovigilance Associate is a Nurse (RN/BSN) and/or Pharmacist (RPh/PharmD) with at least 3 years of experience in Pharmacovigilance
Experience with Global drug safety database is required and MedDRA knowledge utilizing WHO- Drug dictionaries for coding consistency and knowledge of regulatory regulations and guidance
Behaviors/Skills:
Ability to independently identify problems and effectively offer solutions
Must be team player, detail oriented and be willing to work in a fast-paced environment with time-sensitive materials
Must be proficient in using Microsoft Office programs such as Excel, Word and PowerPoint |
| | Company | | Pearl Therapeutics, Inc. | Job Code | | State or Province | | New Jersey | | |
|
