Senior Director, Pharmacovigilance and Drug Safety
About the role
The Senior Director of Pharmacovigilance (PV) will provide strategic, operational, and commercial leadership for the CRO’s Pharmacovigilance and Drug Safety business unit. This role requires an expert leader to oversee global clinical trial safety operations while simultaneously driving the strategic expansion of the CRO’s service portfolio into post-marketing pharmacovigilance. The expansion will follow a phased approach, launching with US post-marketing services to start, followed by scalable growth into full global post-marketing capabilities. The successful candidate will ensure flawless regulatory compliance (FDA, EMA, and ICH) across all active portfolios, design the multi-regional operational infrastructure, and serve as the commercial champion to win and onboard new post-marketing Sponsor accounts.
Key Responsibilities 2. Phased Strategic Portfolio Expansion (US to Global Post-Marketing) Phase 1 Infrastructure (US Focus): Lead the architectural design and implementation of the CRO’s initial US post-marketing safety infrastructure, configuring multi-tenant safety databases for spontaneous, literature, and patient support program case processing. 2. Phased Strategic Portfolio Expansion (US to Global Post-Marketing )Phase 1 Infrastructure (US Focus): Lead the architectural design and implementation of the CRO’s initial US post-marketing safety infrastructure, configuring multi-tenant safety databases for spontaneous, literature, and patient support program case processing Phase 2 Infrastructure (Global Scale): Formulate the roadmap to expand post-marketing services globally, adapting systems to support multi-lingual intake, EU/UK QPPV networks, and diverse international regulatory frameworks. SOP & SDEA Frameworks: Author and launch a comprehensive suite of post-marketing Standard Operating Procedures (SOPs) and Safety Data Exchange Agreement (SDEA) templates, initially aligned with FDA 21 CFR 314/600 and systematically upgraded to meet Global Good Pharmacovigilance Practices (GVP). Capabilities Building: Establish operational workflows for global literature screening, localized digital media safety monitoring, and multi-regional aggregate report compilation. 3. Regulatory Submissions & Aggregate Reporting Expedited Submissions: Ensure flawless compliance with expedited reporting timelines, including FDA 7/15-day clinical trial alerts, FDA 15-day post-marketing requirements, and global E2B(R3) electronic transmissions (FAERS, EVMPD). Aggregate Document Delivery: Collaborate with Regulatory Strategy and Submissions team and with Medical and Scientific Writing service areas for the authoring and submission of periodic regulatory documents bridging pre- and post-marketing formats (e.g., DSURs, PADERs, PBRERs). 4. Commercial Growth & Financial Leadership Business Development: Partner with Sales and Marketing to build commercial capabilities presentations, defend Requests for Proposals (RFPs), and pitch phased post-marketing capabilities to prospective pharma/biotech Sponsors. P&L Ownership: Manage the financial performance, utilization rates, and profit margins of the safety business unit, balancing headcount across clinical trials and expanding post-marketing pipelines.
Minimum Qualifications Education: PharmD, MD, PhD, or a Master’s degree in a life sciences or nursing discipline. Experience: Minimum 10 years of progressive experience in drug safety/pharmacovigilance within a CRO or pharmaceutical setting, with at least 5 years in a CRO leadership role. Dual Portfolio Expertise: Demonstrated, hands-on experience managing both clinical trial safety operations and FDA post-marketing case processing. Global Regulation Command: Profound understanding of FDA regulations (21 CFR 312, 314, 600), ICH guidelines, and global GVP modules required to transition operations from US-centric to global. Growth Track Record: Proven experience building, scaling, or launching a new functional capability or service line (such as expanding from clinical to post-marketing) within a life sciences organization. Systems Mastery: Deep expertise in validated safety databases (Oracle Argus preferred) supporting multi-tenant configurations and global reporting destinations.
Preferred Competencies Experience establishing or managing international safety hubs (e.g., EU, APAC, or LATAM delivery networks). Established reputation in the industry with an active network of pharma/biotech safety executives to aid in business development. Proven ability to manage globally distributed, blended delivery teams (onshore/offshore models).
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Senior Director, Pharmacovigilance and Drug Safety
About the role
The Senior Director of Pharmacovigilance (PV) will provide strategic, operational, and commercial leadership for the CRO’s Pharmacovigilance and Drug Safety business unit. This role requires an expert leader to oversee global clinical trial safety operations while simultaneously driving the strategic expansion of the CRO’s service portfolio into post-marketing pharmacovigilance. The expansion will follow a phased approach, launching with US post-marketing services to start, followed by scalable growth into full global post-marketing capabilities. The successful candidate will ensure flawless regulatory compliance (FDA, EMA, and ICH) across all active portfolios, design the multi-regional operational infrastructure, and serve as the commercial champion to win and onboard new post-marketing Sponsor accounts.
Key Responsibilities 2. Phased Strategic Portfolio Expansion (US to Global Post-Marketing) Phase 1 Infrastructure (US Focus): Lead the architectural design and implementation of the CRO’s initial US post-marketing safety infrastructure, configuring multi-tenant safety databases for spontaneous, literature, and patient support program case processing. 2. Phased Strategic Portfolio Expansion (US to Global Post-Marketing )Phase 1 Infrastructure (US Focus): Lead the architectural design and implementation of the CRO’s initial US post-marketing safety infrastructure, configuring multi-tenant safety databases for spontaneous, literature, and patient support program case processing Phase 2 Infrastructure (Global Scale): Formulate the roadmap to expand post-marketing services globally, adapting systems to support multi-lingual intake, EU/UK QPPV networks, and diverse international regulatory frameworks. SOP & SDEA Frameworks: Author and launch a comprehensive suite of post-marketing Standard Operating Procedures (SOPs) and Safety Data Exchange Agreement (SDEA) templates, initially aligned with FDA 21 CFR 314/600 and systematically upgraded to meet Global Good Pharmacovigilance Practices (GVP). Capabilities Building: Establish operational workflows for global literature screening, localized digital media safety monitoring, and multi-regional aggregate report compilation. 3. Regulatory Submissions & Aggregate Reporting Expedited Submissions: Ensure flawless compliance with expedited reporting timelines, including FDA 7/15-day clinical trial alerts, FDA 15-day post-marketing requirements, and global E2B(R3) electronic transmissions (FAERS, EVMPD). Aggregate Document Delivery: Collaborate with Regulatory Strategy and Submissions team and with Medical and Scientific Writing service areas for the authoring and submission of periodic regulatory documents bridging pre- and post-marketing formats (e.g., DSURs, PADERs, PBRERs). 4. Commercial Growth & Financial Leadership Business Development: Partner with Sales and Marketing to build commercial capabilities presentations, defend Requests for Proposals (RFPs), and pitch phased post-marketing capabilities to prospective pharma/biotech Sponsors. P&L Ownership: Manage the financial performance, utilization rates, and profit margins of the safety business unit, balancing headcount across clinical trials and expanding post-marketing pipelines.
Minimum Qualifications Education: PharmD, MD, PhD, or a Master’s degree in a life sciences or nursing discipline. Experience: Minimum 10 years of progressive experience in drug safety/pharmacovigilance within a CRO or pharmaceutical setting, with at least 5 years in a CRO leadership role. Dual Portfolio Expertise: Demonstrated, hands-on experience managing both clinical trial safety operations and FDA post-marketing case processing. Global Regulation Command: Profound understanding of FDA regulations (21 CFR 312, 314, 600), ICH guidelines, and global GVP modules required to transition operations from US-centric to global. Growth Track Record: Proven experience building, scaling, or launching a new functional capability or service line (such as expanding from clinical to post-marketing) within a life sciences organization. Systems Mastery: Deep expertise in validated safety databases (Oracle Argus preferred) supporting multi-tenant configurations and global reporting destinations.
Preferred Competencies Experience establishing or managing international safety hubs (e.g., EU, APAC, or LATAM delivery networks). Established reputation in the industry with an active network of pharma/biotech safety executives to aid in business development. Proven ability to manage globally distributed, blended delivery teams (onshore/offshore models).