Pharmacovigilance Manager
Amgen
Global Safety Senior Manager – Hematology Oncology
Amgen
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $148,053 - $172,515 per year
Job Level
Senior
About the role
- Support safety assessment activities for medical and scientific operations
- Provide scientific and compliance expertise to the Global Patient Safety (GPS) organization
- Review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Perform data analysis to evaluate safety signals and write up analysis results
- Author safety assessment reports as well as other safety documents and regulatory responses
- Prepare and present the Global Safety Team’s recommendations on safety issues to cross-functional decision-making bodies
- Author and review portions of periodic aggregate safety reports (e.g. PBRERs, DSURs)
- Support clinical trial-related activities, including review of adverse events from clinical trials and input on trial documents
- Assist in development of risk management strategies and risk minimization activities
- Support activities related to new drug applications and other regulatory filings
- Document work in the safety information management system and act as liaison with affiliates
- Undertake activities delegated by the Qualified Person for PV and represent point of contact for health authority inspections and internal audits
Requirements
- Doctorate degree and 2 years of directly related experience OR Master’s degree and 4 years of directly related experience OR Bachelor’s degree and 6 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience
- Preferred: RN, PharmD, or PA
- 6 years of experience in a biotech/pharmaceutical setting
- Previous management and/or mentoring experience
- Experience in signal detection, evaluation and management
- Experience in aggregate data analysis, interpretation and synthesis
- Experience in authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs
- Clinical and/or medical research experience
- Knowledge of ICH guidelines, safety systems (e.g. ARISg and Argus) and MedDRA
