Pharmacovigilance Project Director Job at EVERSANA, Remote

  • EVERSANA
  • Remote

Job Description

At EVERSANA®, we are proud to be a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 6,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 670 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. THE POSITION: This position serves as the primary client-facing pharmacovigilance director responsible for strategic oversight, operational governance, and delivery excellence across assigned client programs. The role provides leadership across pharmacovigilance operations, client governance, inspection readiness, regulatory compliance, and service delivery while ensuring successful execution of project milestones and achievement of client objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by - Serve as the primary point of contact for assigned clients, building trusted relationships and ensuring a high level of customer satisfaction. - Utilize project management principles to plan, track, and drive delivery of milestones, risks, dependencies, and action items. - Lead governance meetings, operational reviews, and client communications. - Lead governance forums, status meetings, and executive reviews, providing clear communication on project progress and key decisions. - Proactively identify, manage, and resolve client concerns, risks, and escalations to ensure successful project outcomes. - Coordinate cross-functional teams to ensure alignment, accountability, and timely execution of client commitments. - Provide oversight of case processing, aggregate reporting, literature surveillance, signal management, and regulatory submissions. - Drive development and maintenance of Safety Management Plans. - Drive service delivery excellence through continuous monitoring of KPIs, quality metrics, and client feedback, ensuring contractual and operational expectations are met or exceeded. - Ensure compliance with FDA, EMA, ICH, and client-specific requirements. - Support audits, inspections, CAPA management, and regulatory inquiries. - Monitor project financials, including billing, invoicing, resource utilization, and budget performance. - Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias. - All other duties as assigned EXPECTATIONS OF THE JOB: - Travel (Less than 15%) - Hours (40-45 Hours per week) The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

Job Tags

Full time

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