Senior Director Of Pharmacovigilance And Drug Safety

Overview

• Lead strategic and operational initiatives for pharmacovigilance and drug safety within a global clinical research organization.
• Oversee clinical trial safety operations and ensure regulatory compliance across multiple global jurisdictions.
• Drive the expansion of post-marketing pharmacovigilance services from US-focused to global capabilities.
• Collaborate with cross-functional teams to develop and implement multi-regional operational infrastructure.
• Ensure flawless regulatory submissions and aggregate reporting for pre- and post-marketing portfolios.
• Develop commercial strategies to attract new clients and expand the service portfolio.
• Manage financial performance, utilization rates, and profit margins for the safety business unit.
• Establish and maintain operational workflows for global literature screening and multi-regional reporting.

Key Responsibilities & Duties

• Direct clinical trial safety operations, including SAE and SUSAR processing, medical review, and tracking.
• Ensure compliance with client-specific SLAs, KPIs, and SMPs for active clinical trials.
• Design and implement post-marketing safety infrastructure, starting with US-focused services.
• Expand post-marketing services globally, adapting systems to support diverse regulatory frameworks.
• Author SOPs and SDEA templates aligned with FDA and global GVP standards.
• Collaborate on regulatory submissions and aggregate reporting for clinical and post-marketing portfolios.
• Develop commercial presentations and defend RFPs to attract new clients.
• Manage globally distributed teams and ensure efficient utilization of resources.

Job Requirements

• PharmD, MD, PhD, or Master’s degree in life sciences or nursing required.
• Minimum of 10 years of progressive experience in pharmacovigilance within CRO or pharmaceutical settings.
• Expertise in managing clinical trial safety operations and FDA post-marketing case processing.
• Profound understanding of FDA regulations, ICH guidelines, and global GVP modules.
• Proven track record in building and scaling new functional capabilities or service lines.
• Deep expertise in validated safety databases, preferably Oracle Argus.
• Experience managing international safety hubs and globally distributed teams.
• Established industry reputation with a network of pharma/biotech safety executives.