Pharmacovigilance Lead - Director
2 days ago
Buffalo
Director, Pharmacovigilance & Safety Operations Full-Time / Remote position Position Overview A growing clinical-stage biotechnology company is seeking a Director to lead global drug safety operations and establish the systems, processes, and infrastructure needed to support an expanding oncology pipeline. This individual will play a central role in ensuring patient safety and regulatory compliance as the organization advances a global Phase 3 clinical program and prepares for future development milestones. This is a hands-on leadership role combining pharmacovigilance operations, safety systems management, regulatory reporting, risk assessment, and vendor oversight. The successful candidate will be responsible for the effectiveness of the company's PV operating model, including the technology and processes used to capture, evaluate, reconcile, track, and report safety information. The Director will partner with Clinical Development, Clinical Operations, Regulatory Affairs, Data Management, Quality, and senior leadership to maintain a robust global safety infrastructure. The ideal candidate has experience in a small or midsize biopharmaceutical environment, is comfortable working across both strategic and technical areas, and can build scalable processes without losing sight of day-to-day execution. Key Responsibilities Pharmacovigilance Operations & Regulatory Reporting • Direct global drug safety operations across clinical development programs, ensuring the accurate and timely handling of adverse event information and compliance with applicable reporting requirements., • Oversee individual case safety report (ICSR) workflows, including intake, triage, case processing, medical review, quality control, follow-up, and expedited reporting., • Manage the preparation, review, and submission of periodic and aggregate safety reports, including DSURs, PSURs/PBRERs, and other applicable regulatory safety documents., • Establish reliable processes for reconciling safety information between the safety database, clinical trial systems, and other relevant data sources., • Monitor reporting timelines, data quality, compliance metrics, and operational performance; identify issues and implement corrective actions., • Support the development and maintenance of safety content for Investigator's Brochures, clinical protocols, informed consent documents, clinical study reports, and regulatory submissions. Safety Systems, Argus & Data Integration • Own the operational effectiveness and ongoing development of the company's pharmacovigilance technology environment, with particular emphasis on Oracle Argus Safety or comparable safety databases., • Lead or oversee safety database configuration, implementation, upgrades, validation, user acceptance testing (UAT), change control, and system maintenance in collaboration with IT and external vendors., • Ensure safety systems are appropriately configured to support case workflows, regulatory reporting rules, business processes, and global compliance requirements., • Oversee interfaces and data exchange between safety databases, electronic data capture (EDC) platforms, clinical trial management systems, and other relevant applications., • Lead reconciliation and integration initiatives to improve data consistency, traceability, reporting accuracy, and operational efficiency across systems., • Establish system requirements, user specifications, testing protocols, validation documentation, and controlled procedures in accordance with applicable regulatory expectations., • Manage system-related issue resolution, vendor performance, access controls, audit trails, and inspection-ready documentation., • Identify opportunities to streamline manual processes, improve data visibility, and strengthen PV operations through better use of technology and automation. Signal Management & Benefit-Risk Assessment • Establish and maintain a structured approach to ongoing safety surveillance, signal detection, signal evaluation, and escalation of emerging safety concerns., • Coordinate reviews of cumulative safety data, relevant scientific literature, and other available sources to identify potential changes in a product's safety profile., • Lead or coordinate benefit-risk evaluations and ensure safety findings are appropriately documented and communicated to relevant stakeholders., • Oversee risk management activities and the development or maintenance of risk management plans and other risk-minimization measures, as applicable., • Partner with clinical and medical experts to evaluate emerging safety issues and determine appropriate follow-up, investigation, and reporting actions., • Support internal safety review meetings and independent safety committees by providing accurate safety data, analyses, and operational coordination. CRO, Vendor & Partner Management • Select, manage, and oversee external pharmacovigilance service providers, including CROs, case-processing vendors, and safety technology providers., • Define service expectations, quality standards, deliverables, and performance metrics; monitor adherence to contractual and regulatory requirements., • Maintain and oversee Safety Data Exchange Agreements (SDEAs) and other agreements governing safety responsibilities with partners and collaborators., • Review vendor outputs, resolve quality or compliance issues, and implement process improvements where needed., • Ensure outsourced activities remain appropriately supervised and that responsibilities are clearly defined between the company and its service providers., • Coordinate audit preparation, inspection readiness, and follow-up of findings related to PV processes, systems, and external partners. Function Development & Cross-Functional Leadership • Build and refine the PV operating model, establishing the infrastructure and capabilities required to support the company's evolving clinical portfolio., • Develop and maintain SOPs, work instructions, policies, quality controls, and documentation standards across safety operations and systems., • Serve as the primary internal resource for PV operational questions, providing practical guidance to teams across Clinical Development, Clinical Operations, Regulatory Affairs, Quality, and Data Management., • Partner with senior leadership to prioritize resources, manage the PV budget, and determine the appropriate balance between internal capabilities and outsourced services., • Establish clear ownership, escalation pathways, and governance processes for safety-related decisions and deliverables., • Mentor colleagues and support the growth of the PV function as organizational needs expand. Required Qualifications • Approximately 5 to 8+ years of progressive pharmacovigilance or drug safety experience, including meaningful responsibility for PV operations, systems, or functional leadership., • Experience supporting clinical-stage drug development within a biotechnology or pharmaceutical company, preferably in an environment with lean internal teams and outsourced service providers., • Demonstrated knowledge of global safety reporting requirements and applicable FDA, EMA, ICH, and GVP standards., • Experience overseeing ICSR processing and review, expedited reporting, aggregate safety reporting, and ongoing safety surveillance., • Practical experience with pharmacovigilance safety databases, particularly Oracle Argus Safety or ARISg., • Experience with safety system implementation, configuration, validation, UAT, upgrades, workflow development, or related technical operations., • Understanding of safety data reconciliation and the interfaces between PV systems and clinical databases, including EDC platforms., • Experience managing CROs, safety vendors, or other outsourced PV activities, with accountability for quality, timelines, and compliance., • Ability to establish procedures, improve workflows, investigate operational issues, and maintain inspection-ready documentation., • Strong organizational, analytical, and communication skills, with the ability to work independently and collaborate effectively across technical and scientific teams. Preferred Qualifications • Experience building, restructuring, or scaling a pharmacovigilance function at a clinical-stage or emerging biotechnology company., • Experience supporting global Phase 3 clinical trials and late-stage development programs., • Oncology drug development experience, ideally involving targeted therapies or small-molecule therapeutics., • Familiarity with kinase inhibitors and the RAS/RAF/MEK pathway is advantageous., • Experience supporting NDA or BLA submissions and associated safety documentation., • Experience with global safety system integrations, database migrations, automation, or process optimization initiatives., • Experience with signal detection tools, regulatory intelligence platforms, or safety data analytics., • Familiarity with EU Qualified Person for Pharmacovigilance (QPPV) responsibilities or global PV governance., • Experience managing external safety partnerships and negotiating or maintaining SDEAs. Work Environment & Opportunity • Fully remote opportunity., • Direct access to senior leadership and cross-functional decision-makers., • Opportunity to shape the company's PV infrastructure, technology environment, and operating processes., • A hands-on role with meaningful ownership as the clinical pipeline advances., • Competitive compensation, equity participation, and comprehensive benefits. #LI-CA1 Pharmacovigilance | Drug Safety Operations | Argus Safety | Clinical Development
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