Global Head of Drug Safety & Pharmacovigilance

City Therapeutics; Cambridge (MA); On-site; USD 385,000 - 405,000; Full time

Benefits offered by this job

On-site work (Kendall Square)

Job summary

City Therapeutics is seeking a Vice President, Drug Safety and Pharmacovigilance in Cambridge, MA to lead global safety strategy and pharmacovigilance operations. This senior medical role provides oversight of safety data, benefit-risk assessments, and compliant PV systems across the portfolio.

Reporting to the Chief Medical Officer, the VP will guide pharmacovigilance strategy, governance, DSURs/PSURs, and regulatory submissions, while partnering with Clinical Development and Regulatory.

Qualifications

• MD or equivalent medical degree required.
• Board certification or relevant postgraduate clinical training preferred.
• Minimum of 12 years of pharmacovigilance, drug safety, or related experience in biotech/pharma/CRO.
• Demonstrated leadership across safety governance and outsourced operations.

Responsibilities

• Develop and lead global pharmacovigilance and drug safety strategy.
• Serve as senior medical authority for safety matters and provide evidence-based assessments.
• Lead safety surveillance, signal validation, and risk mitigation for development assets.
• Establish Safety Review Committees at study, program and portfolio levels.
• Oversee safety reports including DSURs, PBRERs/PSURs and risk management plans.
• Provide input into protocols, ICFs, CSRs, and regulatory submissions.
• Lead responses to health authority safety inquiries with MedDRA search strategies.
• Provide pharmacovigilance leadership for regulatory filings, inspections, and due diligence.
• Represent Drug Safety with FDA/EMA/MHRA and other authorities.
• Develop and maintain pharmacovigilance policies, templates, analytics, and QA.
• Oversee case safety report processing, expedited reporting, reconciliation, and safety DB operations.
• Collaborate with Clinical Development for safety data review and analysis.
• Manage pharmacovigilance CROs and external providers including contracts and budgets.
• Establish KPIs and quality metrics for vendor performance and regulatory compliance.
• Monitor global PV regulations and drive process improvements.
• Build and scale the pharmacovigilance organization as portfolio grows.
• Foster a culture of scientific rigor, collaboration, and patient safety.

Skills

Leadership

Pharmacovigilance

Regulatory strategy

Medical judgment

Executive communication

Safety data analysis

Education

MD or equivalent medical degree

Board certification or clinical training

Job description

City Therapeutics is seeking a Vice President, Drug Safety and Pharmacovigilance in Cambridge, MA to lead global safety strategy and pharmacovigilance operations. This senior medical role provides oversight of safety data, benefit-risk assessments, and compliant PV systems across the portfolio.

Reporting to the Chief Medical Officer, the VP will guide pharmacovigilance strategy, governance, DSURs/PSURs, and regulatory submissions, while partnering with Clinical Development and Regulatory.