Senior Global Safety Scientist

Alpha Clinical Laboratory Inc; New York (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Alpha Clinical Laboratory Inc seeks a Global Patient Safety Scientist to lead safety strategies for clinical development and post-marketing programs. You will aggregate, review, and analyze safety data to support interpretation and benefit-risk assessment.

The role includes signal detection and evaluation, preparation of DSUR/PSUR/RMP, delivering SMT presentations, and active participation in risk management activities and cross-functional teams.

Qualifications

• Master's, PhD, or PharmD required.
• Minimum 5 years of risk management or relevant clinical experience.
• Experience applying FDA, EU and ICH guidelines in pharmacovigilance.

Responsibilities

• Lead signal detection activities for assigned products.
• Evaluate signals and author safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP, responses to authorities).
• Deliver presentations at SMT meetings and participate in clinical study team meetings.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams and with external stakeholders.
• Contribute to SOP and WI development and process improvements.

Skills

Signal detection

Signal evaluation

Safety documents

Presentations

Risk management

Communication

Pharmacovigilance

Cross-functional collaboration

Education

Master's degree

PhD

PharmD

Tools

GPS safety system

Job description

Alpha Clinical Laboratory Inc seeks a Global Patient Safety Scientist to lead safety strategies for clinical development and post-marketing programs. You will aggregate, review, and analyze safety data to support interpretation and benefit-risk assessment.

The role includes signal detection and evaluation, preparation of DSUR/PSUR/RMP, delivering SMT presentations, and active participation in risk management activities and cross-functional teams.