Pharmacovigilance Medicine Expert

Tech Observer; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Tech Observer is seeking a Pharmacovigilance professional to lead signal detection, including case ICSR review, literature review, and monitoring signals from health authorities.

You will evaluate signals, provide recommendations on risk measures for potential drug risks, and conduct aggregate reviews of safety data to support regulatory decisions. 5+ years of PV experience is required.

Qualifications

• 5+ years of PV experience with broad understanding of PV principles and regulations.
• Experience in safety surveillance and aggregate reporting.
• Risk-benefit evaluation expertise.

Responsibilities

• Signal detection including case ICSR review, literature review and signals from health authorities.
• Signal evaluation and providing recommendations of measures for potential drug risks.
• Aggregate review of safety data.

Skills

PV experience

Safety surveillance

Risk-benefit evaluation

Aggregate reporting

Job description

Signal Detection including case ICSR review, literature review & signals from health authorities;Signal evaluation & providing recommendations of appropriate measures in case of potential drug risks;Aggregate review of safety data;

Required Candidate profile

5+years of experience in PV with broad and comprehensive understanding of PV principles, regulations, and practices, especially safety surveillance, risk-benefit evaluation, and aggregate reporting.