PrimeVigilance
Executive Vice President, Pharmacovigilance Operations (East Coast)
PrimeVigilance, Raleigh, North Carolina, United States, 27601
Executive Vice President, Pharmacovigilance Operations (East Coast)
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Executive Vice President, Pharmacovigilance Operations (East Coast)
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PrimeVigilance Get AI-powered advice on this job and more exclusive features. Company Description
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We cover services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to pharmaceutical and biotech partners, maintaining long-lasting relationships and has become a global leader in its field. We cover all therapy areas including medical device. We invest in staff through training and development, value employee experience and well-being, and support a healthy work-life balance to enable high-quality client service. Come and join us in this journey to make a positive impact in patients’ lives. Job Description
The Executive VP, Pharmacovigilance (PV) Operations is responsible for leading and overseeing all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards. This role will manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure the highest level of patient safety and product quality. They will focus on optimizing cost, speed and quality of delivery through leveraging metrics to inform management interventions. Responsibilities
Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations. Develop comprehensive operational strategies that align with the company’s objectives and ensure goals are met through efficient processes. Lead the development and implementation of strategic plans for the expansion of Safety and Pharmacovigilance services in terms of revenue, operational margins and resources. Lead, mentor, and develop PV operational teams, fostering accountability, high performance, and continuous learning. Partner with the Enterprise PMO/BPO to realize the objectives of the value creation plan (VCP). Represent PV operations at senior/executive management meetings, governance boards, and cross-functional leadership forums. Accurately forecast future needs and allocate resources accordingly, planning for upcoming projects and optimizing resource use. Define KPIs and monitor team performance. Operational Excellence
Champion a culture of excellence across global PV operations, embedding best practices, innovation, and continuous improvement to enhance patient safety outcomes. Collaborate with Enterprise PMO/BPO to optimize and standardize end-to-end PV processes, including project management, case processing, literature, medical information, regulatory, and medical affairs activities. Optimize workflows through automation and emerging technologies to improve data accuracy and decision speed. Identify optional process variations and work with commercial leadership to maximize revenue for these options. Monitor KPIs and performance dashboards to proactively track efficiency, regulatory compliance, and signal detection performance. Drive global harmonization of PV processes across regions and partners, and lead inspection readiness and quality initiatives. Foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development to integrate safety insights into product lifecycle management. Process Improvement & Innovation
Drive operational excellence through process mapping, automation, and technology adoption. Evaluate and implement advanced PV tools, AI-supported case processing, and process efficiencies. Lead change management initiatives to adapt PV operations to evolving regulatory and organizational needs. Partner with the Enterprise PMO to realize the value creation plan (VCP) and transform PV processes with automation, analytics, and AI-driven solutions to enhance efficiency and scalability. Streamline workflows to reduce cycle times and strengthen safety data quality. Leverage benchmarking and best practices to implement process improvements and maintain competitive advantage. Implement robust change management for new tools and methodologies across global PV teams and partners. Cross-Functional Collaboration
Act as a strategic bridge between Pharmacovigilance Operations and key internal stakeholders to inform safety intelligence in decision-making across the product lifecycle. Embed PV insights into strategic business planning to ensure patient safety, compliance, and benefit–risk considerations in portfolio management and market expansion. Facilitate global alignment by harmonizing safety processes and communications across affiliates, regional offices, and headquarters. Contribute to governance committees and safety boards, providing expert input for product development, launch readiness, and lifecycle management. Promote a culture of shared accountability for patient safety and cross-departmental ownership of pharmacovigilance excellence. Qualifications
Ideally an advanced degree. 15+ years of pharmacovigilance experience, with at least 10 years in an operational leadership role with P&L responsibilities. In-depth knowledge of global PV regulations, GVP modules, and drug safety principles. Proven track record of managing PV operations in a global environment within a CRO or PV service provider. Strong leadership, project management, and strategic thinking skills. Excellent communication, negotiation, and interpersonal abilities. Experience with safety databases (e.g., Argus, ArisG) and PV software tools. Strategic leadership and decision-making; operational excellence; regulatory compliance and risk management; cross-functional collaboration. High attention to detail and analytical skills. Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all backgrounds can contribute and grow. We Offer
Training and career development opportunities. Strong emphasis on personal and professional growth. Friendly, supportive working environment. Opportunity to work with colleagues around the world, with English as the company language. Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application. Location : Apex, NC Salary : $130,000.00-$170,000.00
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Join to apply for the
Executive Vice President, Pharmacovigilance Operations (East Coast)
role at
PrimeVigilance Get AI-powered advice on this job and more exclusive features. Company Description
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We cover services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to pharmaceutical and biotech partners, maintaining long-lasting relationships and has become a global leader in its field. We cover all therapy areas including medical device. We invest in staff through training and development, value employee experience and well-being, and support a healthy work-life balance to enable high-quality client service. Come and join us in this journey to make a positive impact in patients’ lives. Job Description
The Executive VP, Pharmacovigilance (PV) Operations is responsible for leading and overseeing all operational aspects of global pharmacovigilance activities, ensuring compliance with regulatory requirements, company SOPs, and industry standards. This role will manage PV teams, optimize operational processes, and collaborate cross-functionally to ensure the highest level of patient safety and product quality. They will focus on optimizing cost, speed and quality of delivery through leveraging metrics to inform management interventions. Responsibilities
Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations. Develop comprehensive operational strategies that align with the company’s objectives and ensure goals are met through efficient processes. Lead the development and implementation of strategic plans for the expansion of Safety and Pharmacovigilance services in terms of revenue, operational margins and resources. Lead, mentor, and develop PV operational teams, fostering accountability, high performance, and continuous learning. Partner with the Enterprise PMO/BPO to realize the objectives of the value creation plan (VCP). Represent PV operations at senior/executive management meetings, governance boards, and cross-functional leadership forums. Accurately forecast future needs and allocate resources accordingly, planning for upcoming projects and optimizing resource use. Define KPIs and monitor team performance. Operational Excellence
Champion a culture of excellence across global PV operations, embedding best practices, innovation, and continuous improvement to enhance patient safety outcomes. Collaborate with Enterprise PMO/BPO to optimize and standardize end-to-end PV processes, including project management, case processing, literature, medical information, regulatory, and medical affairs activities. Optimize workflows through automation and emerging technologies to improve data accuracy and decision speed. Identify optional process variations and work with commercial leadership to maximize revenue for these options. Monitor KPIs and performance dashboards to proactively track efficiency, regulatory compliance, and signal detection performance. Drive global harmonization of PV processes across regions and partners, and lead inspection readiness and quality initiatives. Foster cross-functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development to integrate safety insights into product lifecycle management. Process Improvement & Innovation
Drive operational excellence through process mapping, automation, and technology adoption. Evaluate and implement advanced PV tools, AI-supported case processing, and process efficiencies. Lead change management initiatives to adapt PV operations to evolving regulatory and organizational needs. Partner with the Enterprise PMO to realize the value creation plan (VCP) and transform PV processes with automation, analytics, and AI-driven solutions to enhance efficiency and scalability. Streamline workflows to reduce cycle times and strengthen safety data quality. Leverage benchmarking and best practices to implement process improvements and maintain competitive advantage. Implement robust change management for new tools and methodologies across global PV teams and partners. Cross-Functional Collaboration
Act as a strategic bridge between Pharmacovigilance Operations and key internal stakeholders to inform safety intelligence in decision-making across the product lifecycle. Embed PV insights into strategic business planning to ensure patient safety, compliance, and benefit–risk considerations in portfolio management and market expansion. Facilitate global alignment by harmonizing safety processes and communications across affiliates, regional offices, and headquarters. Contribute to governance committees and safety boards, providing expert input for product development, launch readiness, and lifecycle management. Promote a culture of shared accountability for patient safety and cross-departmental ownership of pharmacovigilance excellence. Qualifications
Ideally an advanced degree. 15+ years of pharmacovigilance experience, with at least 10 years in an operational leadership role with P&L responsibilities. In-depth knowledge of global PV regulations, GVP modules, and drug safety principles. Proven track record of managing PV operations in a global environment within a CRO or PV service provider. Strong leadership, project management, and strategic thinking skills. Excellent communication, negotiation, and interpersonal abilities. Experience with safety databases (e.g., Argus, ArisG) and PV software tools. Strategic leadership and decision-making; operational excellence; regulatory compliance and risk management; cross-functional collaboration. High attention to detail and analytical skills. Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all backgrounds can contribute and grow. We Offer
Training and career development opportunities. Strong emphasis on personal and professional growth. Friendly, supportive working environment. Opportunity to work with colleagues around the world, with English as the company language. Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application. Location : Apex, NC Salary : $130,000.00-$170,000.00
#J-18808-Ljbffr