Senior Director, Patient Safety & Risk Management

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 276,000 - 414,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated seeks a Patient Safety Senior Medical Director to lead safety and risk management for assigned products during pre- and post-approval. You will spearhead risk management activities, aggregate safety reporting, signaling, labeling and DST work, and participate in individual case medical reviews.

You will represent safety on clinical teams and regulatory filings, and drive SOP development and inspections.

Qualifications

• MD/DO or equivalent ex-US medical degree required.
• Typically requires 7 years of experience, or the equivalent combination of education and experience.
• Strong knowledge of safety reporting (DSUR/PSUR) and regulatory interactions.

Responsibilities

• Leads safety and risk management for assigned products across pre/post-approval
• Oversees aggregate safety reporting, signaling, labeling and DST activities
• Represents safety on cross-functional study/program teams and regulatory filings
• Guides SOP development, audits and inspections in GPS
• Mentors staff in evaluation of adverse events and case safety reviews

Skills

GCP & ICH knowledge

Benefit-Risk principles

Multi-tasking

Communication with senior leaders

Independent judgement

Matrix communication

General Medicine

Data evaluation

Safety reviews of AEs/SAEs

Education

MD/DO or equivalent ex-US

Job description

Vertex Pharmaceuticals Incorporated seeks a Patient Safety Senior Medical Director to lead safety and risk management for assigned products during pre- and post-approval. You will spearhead risk management activities, aggregate safety reporting, signaling, labeling and DST work, and participate in individual case medical reviews.

You will represent safety on clinical teams and regulatory filings, and drive SOP development and inspections.