Vice President, Drug Safety and Pharmacovigilance

City Therapeutics • Cambridge, MA

11h • $385,000 - $405,000 • Onsite

About The Position

City Therapeutics is engineering RNAi-based medicines and building a diversified research and development pipeline. Reporting directly to the Chief Medical Officer, the Vice President of Drug Safety and Pharmacovigilance will serve as the company’s senior physician safety expert and provide strategic leadership across pharmacovigilance and drug safety activities. The role is responsible for the global safety strategy, governance, surveillance, reporting, and risk-management capabilities across the clinical-stage portfolio. The Vice President will provide medical oversight of safety data, lead benefit-risk assessments, and ensure scalable, compliant, inspection-ready pharmacovigilance systems. The role partners closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Quality, Research, and external partners, combining strategic leadership with hands-on execution.

The position is onsite five days per week at City Therapeutics’ Kendall Square offices. The company describes its working model as designed to foster connection, fairness, and growth, and says it is flexible and supportive when individual needs arise. The role is eligible for an annual bonus, equity compensation, and a competitive benefits package. The stated base salary range is $385,000–$405,000.

Requirements

• MD or equivalent medical degree required.
• A minimum of 12 years of progressive experience in pharmacovigilance, drug safety, clinical development, or a closely related function within the biotechnology, pharmaceutical, or CRO industry.
• Significant leadership experience, including responsibility for pharmacovigilance strategy, teams, governance, and outsourced operations.
• Demonstrated experience building or scaling a pharmacovigilance function within a clinical-stage biotechnology or pharmaceutical company.
• Deep knowledge of global pharmacovigilance regulations and guidance, including pre- and post-marketing safety requirements in the United States and European Union.
• Demonstrated expertise in safety surveillance, signal management, aggregate reporting, risk management, and benefit-risk assessment.
• Strong experience supporting clinical development programs and regulatory submissions, including integrated safety analyses and responses to health authority inquiries.
• Proven experience leading regulatory authority interactions and supporting successful pharmacovigilance inspections.
• Experience overseeing CROs, pharmacovigilance service providers, safety databases, and other outsourced operations.
• Exceptional medical judgment, analytical thinking, scientific writing, and executive communication skills.
• Ability to communicate complex safety information clearly and provide well-supported recommendations to senior leaders and cross-functional teams.
• Ability to lead effectively in a fast-paced, growing organization while remaining willing to engage directly in critical deliverables.

Nice To Haves

• Board certification or relevant postgraduate clinical training is strongly preferred.
• Experience in a biotechnology or start-up environment is strongly preferred.
• Experience with RNA therapeutics or therapeutic areas relevant to City Therapeutics’ pipeline is a plus.

Responsibilities

• Develop and lead the global pharmacovigilance and drug safety strategy in alignment with clinical development plans and corporate objectives.
• Serve as the senior medical authority for safety matters and provide evidence-based benefit-risk assessments and recommendations to executive leadership.
• Lead ongoing safety surveillance and signal detection, including signal validation, evaluation, prioritization, communication, and risk mitigation.
• Establish and lead Safety Review Committees and other safety-governance forums at study, program, and portfolio levels.
• Oversee preparation, medical review, and approval of aggregate safety reports, including DSURs, PBRERs/PSURs, risk-management plans, and ad hoc safety assessments.
• Provide safety input into clinical protocols, informed consent forms, Investigator’s Brochures, Clinical Study Reports, integrated summaries of safety, development plans, and regulatory submissions.
• Lead strategies and responses to regulatory authority inquiries involving safety, including appropriate MedDRA search and analysis strategies.
• Provide pharmacovigilance leadership for regulatory filings, health authority meetings, inspections, due diligence, and other critical company initiatives.
• Represent Drug Safety and Pharmacovigilance in interactions with the FDA, EMA, MHRA, and other global regulatory authorities.
• Build and maintain pharmacovigilance policies, procedures, templates, analytics, reporting infrastructure, quality controls, and inspection-readiness capabilities.
• Oversee individual case safety report processing, expedited reporting, reconciliation activities, and safety database operations.
• Partner with Clinical Development and Biometrics on safety data review, database adjudication, statistical analysis, and interpretation.
• Select, oversee, and manage pharmacovigilance CROs and other external service providers, including performance, quality, contracts, budgets, invoices, and issue resolution.
• Establish and monitor key performance indicators and quality metrics for vendor regulatory compliance, contractual obligations, timelines, and quality standards.
• Monitor changes in global pharmacovigilance regulations and industry standards, lead gap assessments, and implement process improvements.
• Build and develop the pharmacovigilance organization as the portfolio advances, including workforce planning, talent development, and succession planning.
• Foster a culture of scientific rigor, collaboration, accountability, urgency, and commitment to patient safety.

Benefits

• Annual bonus eligibility
• Equity compensation
• Competitive benefits package
• Flexible and supportive approach to balancing home life with life at City when individual needs arise

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree