Manager, Safety Scientist

Scorpion Therapeutics; United States; Hybrid; USD 120,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager, Safety Scientist to oversee signal detection and safety assessments, contributing to pharmacovigilance and regulatory submissions. This role emphasizes collaboration with cross-functional teams to ensure robust safety evaluations.

The ideal candidate has a PharmD, RN, or PhD/MS with 2+ years in PV, plus familiarity with Argus, MedDRA, and data mining tools. Remote or hybrid work arrangements are available, supporting global regulatory engagement.

Qualifications

• 2+ years in pharmacovigilance within the biopharma industry.
• Experience with global regulatory requirements.
• Experience with safety data analysis and safety databases (e.g., Argus).
• Knowledge of MedDRA and data mining tools is preferred.

Responsibilities

• Perform signal detection, safety data evaluation, author safety assessments, support clinical trial safety monitoring, prepare safety documentation for regulatory submissions, and respond to health authority inquiries.
• Collaborates with Product Safety Leads, cross-functional teams, and safety committees, providing scientific insights and safety communication support.

Skills

Signal detection

Safety data evaluation

Safety assessments

Pharmacovigilance

Regulatory reporting

Data analysis

Education

PharmD, RN, or PhD/MS in medical or biological sciences

Tools

Argus

MedDRA

Spotfire

PowerBI

Job description

Role:

Manager, Safety Scientist, supports compound safety evaluation and signal detection within pharmacovigilance, contributing to risk assessment, regulatory reporting, and safety data analysis.

Responsibilities:

perform signal detection, safety data evaluation, author safety assessments, support clinical trial safety monitoring, prepare safety documentation for regulatory submissions, and respond to health authority inquiries.

Collaborates with Product Safety Leads, cross-functional teams, and safety committees, providing scientific insights and safety communication support.

Requirements:

PharmD, RN, or PhD/MS in medical or biological sciences; 2+ years in pharmacovigilance within the biopharma industry; experience with global regulatory requirements, safety data analysis, and safety databases (e.g., Argus).

Preferred:

knowledge of MedDRA, data mining tools (Spotfire, PowerBI), and familiarity with safety reporting and risk management plans.

HighValue:

supports oncology or cancer therapeutic programs, with a focus on safety evaluation, regulatory compliance, and signal management; less than 10% travel; global regulatory environment involvement.

Work setup:

remote or hybrid, with collaborative matrix team engagement.