Senior Global Pharmacovigilance Lead — Safety & Risk

BioSpace; Washington (District of Columbia); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Group medical/dental/vision

Discretionary annual bonus

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is a biotechnology company dedicated to serving patients living with serious illnesses across oncology, inflammation, general medicine, and rare disease. As Global Pharmacovigilance Senior Manager, you will work with Therapeutic Safety Teams to oversee safety assessment activities for medical and scientific operations.

You will direct safety signal detection, evaluation, and management, review safety data from clinical studies, and lead development of risk management strategies and

Qualifications

• Doctorate or higher with industry pharmacovigilance experience
• Experience with signal detection and safety data analysis
• Experience in literature surveillance and aggregate data interpretation

Responsibilities

• Directs planning, preparation, writing of aggregated safety reports
• Leads liaison with affiliates and internal Amgen partners on products
• Oversees safety in clinical trials and study documents
• Reviews AEs/SAEs and safety data listings
• Develops safety data collection forms for trials
• Represents safety in cross-functional meetings and risk management

Skills

Signal detection

Safety data analysis

Literature surveillance

Clinical and medical judgment

Drug safety experience

Clinical research experience

Regulatory filings support

Education

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma/GED

Job description

Amgen is a biotechnology company dedicated to serving patients living with serious illnesses across oncology, inflammation, general medicine, and rare disease. As Global Pharmacovigilance Senior Manager, you will work with Therapeutic Safety Teams to oversee safety assessment activities for medical and scientific operations.

You will direct safety signal detection, evaluation, and management, review safety data from clinical studies, and lead development of risk management strategies and