Pharmacovigilance Specialist (home-based)
NOTE: This role may be home-based from any location in the U.S.
The Pharmacovigilance (PV) Specialist is responsible for ensuring accurate collection, database entry, review, and reporting of clinical trial and post-marketing safety data. The PV Specialist may be required to assist senior staff in signal generation, safety analysis activities, and in the development and implementation of departmental processes and guidelines.
- Perform safety review and analysis of adverse events for clinical and post-marketing products, including: triage, case review, narrative writing, coding, evaluation of listedness/expectedness, query generation, query tracking, and interface with reporters or investigators
- Interface with medical reviewers and clients on adverse events and other safety-related issues
- Participate in literature review activities related to adverse event reporting
- Generate necessary safety reports with minimal supervision
- Assist with preparation of safety reports (e.g. Periodic Reports and Periodic Safety Update Reports, and interface with safety writer as needed
- Assist with preparation of Risk Management documentation and activities
- Assist with Case Report Form (CRF) review as requested, assessing data provided on CRFs to ensure medical safety and compliance, and generating queries
- Position requires a Bachelor's degree, preferably in a medical/scientific field (eg., BSN or R.Ph.), plus 2 years of relevant PV/Clinical experience.
- Must possess good clinical interpretation skills based on limited information, a strong understanding of medical terminology, and knowledge of FDA and ICH regulations.
- Understanding coding standards using MedDRA or other coding dictionaries is beneficial, as is drug safety database knowledge.
- Strong oral and written communication skills and the ability to work independently or with minimal guidance is essential.
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