Head of Drug Safety and Pharmacovigilance

The Head of Drug Safety and Pharmacovigilance is responsible for the global strategy, medical leadership, and operational oversight of drug safety and pharmacovigilance activities at TB Alliance throughout the product lifecycle. Reporting to the Chief Medical Officer, this individual serves as the senior safety leader and advises leadership on benefit-risk decisions, emerging safety issues, and development priorities. The role leads a lean internal function supported by outsourced service providers, with accountability for the quality, compliance, and timely delivery of delegated activities. This includes oversight of safety vendors across trials and post-marketing activities, aggregate and expedited safety reporting, and communication with Health Authorities, investigators, clinical study teams, and business partners. The Head develops and maintains the safety strategy, governance, SOPs, and quality standards for TB Alliance.

This individual will also serve as an external representative of TB Alliance with Health Authorities and business partners, ensuring that safety data exchange is timely, medically sound, and compliant. The role combines leadership with hands-on medical judgment and involvement in critical safety reviews, while directing vendors and consultants responsible for routine execution.

Position Responsibilities:

• Chair the safety management team, which oversees safety monitoring for all compounds and characterizes the safety profile and benefit-risk evaluation for individual compounds at TB Alliance, while being accountable for signal detection and safety review in collaboration with cross-functional teams and external business partners. Establish escalation pathways and ensure safety decisions and follow-up actions are documented. Lead risk management planning with oversight for implementation and evaluation of risk minimization measures
• Manage and optimize IB, DSUR, and other applicable aggregate safety report development across compounds. In collaboration with Clinical Development, ensure thorough medical review of IBs and determine the optimal timing of safety-driven updates.  Management of the RSI across compounds to align with current evidence.
• Provide medical review of aggregate reports and guide the analysis and synthesis of trial and post-marketing safety data, using appropriate analytics to identify trends, assess signals and communicate actionable benefit-risk recommendations to development teams and senior leadership.
• Lead safety strategy and benefit-risk assessment for NDA and MAA dossiers and labeling updates, partnering with Regulatory Affairs on submission content, Health Authority interactions, and responses to safety questions.
• Provide strategic safety input into study design while anticipating safety concerns and actively participate in study protocol development, including safety monitoring, stopping rules, and risk mitigation, as well as the analysis and synthesis of trial data with specific attention to safety sections and benefit-risk evaluation. Provide medical input into TB Alliance partner study protocols and other trial documents as appropriate and advise on safety monitoring committees (SMC) to ensure SMC recommendations inform program decisions.
• Manage and ensure the quality and compliance of PV operational activities delivered by external vendors, including case processing, literature surveillance, reconciliation, database maintenance, and regulatory reporting. Define clear responsibilities, deliverables, and escalation procedures.
• Provide medical oversight to contractors, consultants, and non-physician team members involved in preparing safety documents. Set review standards and ensure access to qualified safety physicians for delegated medical reviews.
• Lead vendor selection, qualification, contracting, and ongoing oversight in partnership with Quality Assurance and relevant functions. Establish service levels, performance metrics, governance reviews, and remediation plans; oversee budgets and resource allocation to ensure reliable, cost-effective delivery.
• Provide strategic input into business development and licensing activities, including safety due diligence, assessment of product risks, and the PV resources and obligations required to support partnerships. Ensure that Safety Data Exchange Agreements are executed for all development, licensing, commercialization, and distribution partnerships to meet regulatory requirements and protect TB Alliance assets and provide oversight for the requirements set forth within the Agreement, while fostering effective working relationships.
• Lead the strategy, operating model, and budget of the department, aligning internal capabilities and outsourced resources with portfolio priorities. Alert senior management to significant safety risks and quality or compliance deficiencies and ensure corrective actions are implemented.
• Ensure compliant PV processes are in place for the collection, collation, evaluation, and submission of individual case safety reports and aggregate reports in accordance with international regulatory requirements, as well as full adherence to GxP standards. Maintain sponsor oversight and accountability for activities delegated to vendors.
• Ensure effective systems to monitor reporting compliance, vendor quality, data integrity and corrective and preventive actions, partnering with Quality Assurance to maintain inspection readiness, lead the PV response to audits and inspections, and ensure findings are resolved.
• Effectively manage and develop a lean internal pharmacovigilance team and network of external experts and service providers and determine a strategy for building a scalable PV function, for handling volume and growth from IND phase through post-marketing obligations.
• Responsible for compliance with applicable GxP regulations in performing the functions of the job and completion of applicable regulatory trainings provided by the TB Alliance.

Requirements:

• Medical degree (MD or equivalent); board certification in a relevant specialty preferred.
• Significant biopharmaceutical industry experience, including at least 10 years in Pharmacovigilance and substantial senior leadership experience overseeing global safety strategy, medical safety, and PV operations.
• Demonstrated success leading a lean safety function in a biotech or similarly resource-constrained organization with substantial outsourcing. Experience selecting and managing PV vendors, negotiating scope and service levels, overseeing budgets, and holding providers accountable for quality and delivery.
• Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance, including clinical trial safety monitoring and reporting, post-marketing surveillance, case processing, safety agreements, and worldwide Health Authority reporting.
• Experience leading pharmacovigilance inspection readiness and responses to major global Health Authority inspections, with oversight of quality systems, SOPs, performance metrics, compliance monitoring, training, and corrective and preventive actions.
• Ability to assess the evolving regulatory landscape, interpret complex safety data, evaluate benefit-risk, and make sound medical decisions. Experience with regulatory submissions, labeling, risk management plans, and Health Authority safety interactions.
• Experience overseeing safety databases and outsourced systems, with an understanding of data integrity, validation, reconciliation, analytics, and reliable access to safety information.
• Proven ability to lead and develop internal teams and external providers, influence senior leaders and cross-functional teams, and manage complex partnerships. Experience across clinical development and post-marketing safety and the ability to support multiple programs simultaneously.
• Excellent medical judgment, communication, analytical, and organizational skills; ability to translate safety findings into clear recommendations and balance strategic leadership with hands-on involvement in a dynamic environment.

Location:

Position based in New York City, NY (US). Other relevant locations may be considered. A flexible, hybrid schedule is available; domestic and international travel may be required.

Salary and Benefits:

As part of our overall compensation package, we offer a competitive salary, comprehensive health benefits, generous retirement contributions, and work/life flexibility designed to support employees and their immediate family. Starting salary is expected to be in the range of US $300K – $375K. Exact salary will be commensurate with skills and experience and adjusted to reflect local currency for candidates outside the US. 

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Instructions:

Interested candidates may submit their CVs along with a cover letter to jobs@tballiance.org.

TB Alliance is an Equal Employment Opportunity employer. This job description should not be construed to imply that these requirements are the only standards for the position. Other duties may be assigned. TB Alliance has the right to revise this job description at any time. TB Alliance is an “at will” employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and TB Alliance.  

Organizational Information:

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster, affordable tuberculosis drugs that are available to those who need them.Through innovative science and with partners around the globe, we lead a global effort to ensure development of and equitable access to faster, better tuberculosis cures that will advance global health and prosperity.

With an annual operating budget of approximately $60 million, the TB Alliance leads the advancement of the most comprehensive R&D portfolio of TB drug candidates in history. Additionally, the TB Alliance drives efforts to ensure regulatory approval, country adoption of new regimens, and widespread availability of new drug regimens to patients. For more information, please access the website: www.www.tballiance.org.