Patient Safety and Pharmacovigilance Specialist (Fully Remote)

WEP Clinical; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

WEP Clinical partners with biopharmaceutical sponsors to deliver end-to-end clinical trial and market access solutions, helping bring treatments to patients. Over 15 years of global experience in 150+ countries, we foster a collaborative culture that encourages innovation and growth.

We are seeking a Pharmacovigilance professional in the United States to oversee international adverse event activities, monitor PV metrics, and ensure regulatory compliance across global sites.

Qualifications

• 3+ years of drug safety/pharmacovigilance experience.
• Knowledge of FDA/ICH regulations.

Responsibilities

• Execute international adverse event and pharmacovigilance activities per regulatory requirements.
• Coordinate adverse event activities for global sites.
• Monitor PV system metrics to ensure compliance and effectiveness.
• Author Safety Monitoring Plans and process adverse events in Argus.
• Provide training and support audits for PV compliance.

Skills

Pharmacovigilance

Adverse Event Monitoring

Regulatory Compliance

Education

Bachelor's in Life Sciences

Advanced degree preferred

Tools

Argus Safety Database

Job description

• Execute international adverse event and pharmacovigilance activities per regulatory requirements.
• Coordinate adverse event activities for global sites.

What You'll Do:

• Monitor PV system metrics to ensure compliance and effectiveness.
• Author Safety Monitoring Plans and process adverse events in Argus.
• Provide training and support audits for PV compliance.

What You'll Need:

• Bachelor's in life sciences; advanced degree preferred.
• 3+ years drug safety/pharmacovigilance experience.
• Knowledge of Argus Safety Database and FDA/ICH regulations.

WEP Clinical

WEP Clinical partners with biopharmaceutical sponsors to deliver end-to-end clinical trial and market access solutions, helping bring treatments to patients. Over 15 years of global experience in 150+ countries, we foster a collaborative culture that encourages innovation and growth.