Medical Director, Pharmacovigilance

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Medical Director of Pharmacovigilance to oversee safety activities for investigational and marketed products, with a focus on Phase 3 trials. You will lead safety surveillance, signal detection, and safety strategy, collaborating across clinical development, regulatory, and CROs.

Requirements include an MD and 7+ years in pharmacovigilance, with strong FDA/EMA/ICH knowledge and experience with DSURs, PSURs, and adverse event reviews.

Qualifications

• MD degree with 7+ years in pharmacovigilance and safety reporting.
• Deep knowledge of FDA/EMA/ICH guidelines and GxP standards.
• Proficiency with safety databases Argus, MedDRA, WHO DD.
• Understanding of the clinical development lifecycle.

Responsibilities

• Lead safety surveillance, signal detection, and benefit-risk assessments.
• Oversee aggregate safety reporting (DSURs, PSURs, IND reports).
• Medical review of adverse events and vendor oversight.
• Develop and implement safety strategy in collaboration with cross-functional teams.
• Contribute to safety documentation and regulatory responses; mentor team.

Skills

Pharmacovigilance

Safety reporting

Signal detection

Regulatory submissions

Team leadership

Vendor oversight

GxP knowledge

Education

MD degree

Tools

Argus

MedDRA

WHO Drug Dictionary

Job description

Role

Medical Director of Pharmacovigilance overseeing safety activities for investigational and marketed products, primarily supporting Phase 3 clinical trials.

Responsibilities

lead safety surveillance, signal detection, benefit-risk assessments, aggregate safety reporting (DSURs, PSURs, IND reports), medical review of adverse events, vendor oversight, and safety strategy development. Collaborate closely with clinical development, regulatory, medical affairs, and external CROs; contribute to safety documentation and regulatory responses; mentor team members.

Requirements

MD degree; 7+ years in pharmacovigilance with experience in safety reporting, signal detection, case review, and regulatory submissions; deep knowledge of FDA, EMA, ICH guidelines, and GxP standards; proficiency with safety databases like Argus, MedDRA, WHO Drug Dictionary; understanding of clinical development lifecycle.

Preferred

experience with risk management, safety governance, and cross-functional communication.

HighValue

senior pharmacovigilance leadership supporting global regulatory compliance, with significant engagement in Phase 3 trials, safety strategy, and vendor management.

Work setup

remote or Waltham, MA, with approximately 10-15% travel.