Patient Safety PVSci Manager

Scorpion Therapeutics; United States; Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

Remote work option

Job summary

Scorpion Therapeutics is seeking a GPS Pharmacovigilance Science (PVSci) Manager to lead safety data monitoring, assessment, and regulatory reporting for Vertex products. The role collaborates with cross-functional teams and regulatory bodies to ensure robust safety oversight.

Responsibilities include coordinating safety data review, preparing aggregate safety reports, and developing safety content for clinical and regulatory documentation. Remote work option is available in this role.

Qualifications

• Advanced healthcare degree or relevant experience.
• Minimum of 2 years in pharmacovigilance with data analysis and medical writing.
• Familiarity with aggregate safety reports, industry drug development practices, and electronic systems.

Responsibilities

• Coordinate safety data review.
• Prepare aggregate safety reports.
• Conduct signal detection and risk management activities.
• Develop safety content for clinical/regulatory documents.
• Liaise with regulatory teams.

Skills

Pharmacovigilance

Safety data monitoring

Data analysis

Medical writing

Regulatory reporting

Signal detection

Cross-functional collaboration

Education

Advanced healthcare degree

Job description

Role: GPS Pharmacovigilance Science (PVSci) Manager leading safety data monitoring, assessment, and regulatory reporting for Vertex products.

Responsibilities:

• coordinate safety data review
• prepare aggregate safety reports
• conduct signal detection and risk management activities
• develop safety content for clinical/regulatory documents
• and liaise with regulatory teams.

Requirements:

• advanced healthcare degree or relevant experience
• minimum of 2 years in pharmacovigilance with data analysis and medical writing
• familiarity with aggregate safety reports, industry drug development practices, and electronic systems.

High-Value: pharmacovigilance, safety signal detection, aggregate reporting, regulatory submissions, cross-functional collaboration, remote work option, 2+ years experience.