Vice President, Pharmacovigilance

Scorpion Therapeutics; Boston (MA); On-site; USD 250,000 - 380,000; Full time

Job summary

Scorpion Therapeutics is seeking a Vice President of Global Drug Safety & Pharmacovigilance to lead the pharmacovigilance strategy and operations ensuring patient safety for company products. The role oversees safety data exchange, signal detection, benefit-risk assessments, and risk management.

You will chair safety review committees, supervise regulatory filing documentation (IND/BLA/MAA), review safety reports, and ensure PV regulatory compliance while guiding CRO performance and PV staff

Qualifications

• MD with clinical and industry PV experience.
• 15+ years in drug safety/pharmacovigilance in biotech/pharma.
• Proven leadership in high-performing teams.
• Expert knowledge of global PV regulations (EMA/FDA/ICH).

Responsibilities

• Develop PV processes and policies, oversee safety data exchange, lead signal detection, and risk management.
• Chair safety review committees.
• Oversee safety documentation for regulatory filings (IND/BLA/MAA) and review safety reports.
• Monitor CRO performance and recruit, develop, and lead PV staff.

Skills

PV leadership

Regulatory knowledge

Global regulatory knowledge

Risk management

Safety data management

Education

MD degree

Job description

Role

Vice President of Global Drug Safety & Pharmacovigilance, leading the pharmacovigilance strategy and operations to ensure patient safety for company products.

Responsibilities

• develop PV processes and policies, oversee safety data exchange, lead signal detection, benefit-risk assessments, and risk management
• chair safety review committees
• oversee safety documentation for regulatory filings (IND/BLA/MAA), review safety reports, and ensure PV compliance
• monitor CRO performance
• recruit, develop, and lead PV staff

Requirements

• MD with clinical and industry experience
• at least 15 years in drug safety/pharmacovigilance within biotech/pharma
• proven leadership in high-performing teams
• expert knowledge of global PV regulations (EMA/FDA/ICH)

High-Value

senior leadership, pharmacovigilance strategy, global regulatory compliance, cross-functional collaboration with clinical development, safety data oversight

Work Setup

not specified