Vice President, Drug Safety and Pharmacovigilance

City Therapeutics•Cambridge, MA

1d•$385,000 - $405,000•Onsite

About The Position

City Therapeutics is seeking a Vice President of Drug Safety and Pharmacovigilance to serve as its senior physician safety expert and provide strategic leadership across pharmacovigilance and drug safety activities. Reporting directly to the Chief Medical Officer, this executive will establish and lead global safety strategy, governance, surveillance, reporting, and risk-management capabilities across the company’s clinical-stage portfolio. The role provides medical oversight of safety data, leads benefit-risk assessments, and ensures scalable, compliant, and inspection-ready pharmacovigilance systems. The Vice President will collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Quality, Research, and external partners. The role combines strategic leadership with direct execution in a growing biotechnology company and includes developing the pharmacovigilance organization as the portfolio advances. The position is onsite at City Therapeutics’ Kendall Square offices five days per week. The company says it provides flexibility and support when individual needs arise. Compensation includes a base salary range of $385,000–$405,000, eligibility for an annual bonus and equity compensation, and a competitive benefits package. City Therapeutics is an Equal Opportunity and Affirmative Action employer and accepts applications from direct applicants only; recruitment agency submissions will not be accepted.

Requirements

MD or equivalent medical degree.
At least 12 years of progressive experience in pharmacovigilance, drug safety, clinical development, or a closely related function in 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 engaging directly in critical deliverables.

Nice To Haves

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

Responsibilities

Develop and lead the company’s 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 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 safety summaries, development plans, and regulatory submissions.
Lead strategy and preparation of responses to regulatory authority inquiries involving safety, including 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.