PrimeVigilance
Executive Vice President, Pharmacovigilance Operations (East Coast)
PrimeVigilance, Raleigh, North Carolina, United States, 27601
Executive Vice President, Pharmacovigilance Operations (East Coast)
Apply for the Executive Vice President, Pharmacovigilance Operations (East Coast) role at PrimeVigilance.
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid‑size pharmacovigilance service provider established in 2008. With a global presence across Europe, North America and Asia, we deliver medical information, pharmacovigilance, regulatory affairs and quality assurance services. We prioritise training and employee development, fostering a healthy work‑life balance and a culture of continuous learning. Our mission is to positively impact patients’ lives through high‑quality safety and regulatory support for pharmaceutical and biotechnology partners.
Job Description The Executive VP, Pharmacovigilance 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 manages PV teams, optimises operational processes and collaborates cross‑functionally to ensure the highest level of patient safety and product quality. Key areas of focus include cost optimisation, speed and quality of delivery informed by metrics.
Leadership & Strategy
Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations.
Develop comprehensive operational strategies that align with the company’s overall objectives, ensuring long‑term goals are met through efficient processes.
Plan expansion of safety and PV services to drive revenue, operational margins and resource utilisation.
Lead, mentor and develop PV operational teams, fostering accountability and continuous learning.
Partner with Enterprise PMO/BPO to realise the objectives of the Value Creation Plan.
Represent PV operations at senior/executive management meetings, governance boards and cross‑functional leadership forums.
Accurately forecast future resource needs and allocate accordingly.
Define KPIs and monitor team performance.
Operational Excellence
Champion a culture of excellence across global PV operations, embedding best practices, innovation and continuous improvement.
Collaborate with Enterprise PMO/BPO to optimise and standardise end‑to‑end pharmacovigilance processes, ensuring efficient, compliant and high‑quality execution of PV projects.
Streamline workflows, leverage automation and emerging technologies to improve data accuracy, reporting timeliness and decision‑making speed.
Identify optional process variations and engage commercial leadership to maximise revenue opportunities.
Monitor KPIs and performance dashboards to track operational efficiency, compliance metrics and signal detection performance.
Drive global harmonisation of PV processes across regions, affiliates and partners to ensure consistent execution and regulatory alignment.
Lead inspection readiness and quality excellence initiatives, ensuring systems, documentation and processes exceed regulatory expectations.
Integrate safety insights into strategic product lifecycle management through collaboration with Regulatory Affairs, Quality, Medical Affairs and Clinical Development.
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 organisational needs.
Collaborate with Enterprise PMO/BPO to realise the objectives of the Value Creation Plan.
Leverage data analytics and AI‑driven solutions to enhance efficiency, accuracy and scalability.
Streamline workflows to optimise resource allocation, reduce cycle times and strengthen safety data quality.
Implement industry benchmarking and best practices to drive competitive advantage.
Engage Enterprise PMO/BPO to ensure adherence to corporate governance for ongoing change initiatives.
Cross‑Functional Collaboration
Act as a strategic bridge between Pharmacovigilance Operations and key internal stakeholders, ensuring safety intelligence informs corporate decision‑making across the product lifecycle.
Embed PV insights into strategic business planning, ensuring safety, compliance and benefit‑risk considerations are central to portfolio management.
Facilitate global alignment by harmonising safety processes and communications between affiliates, regional offices and headquarters.
Participate in governance committees and safety boards, providing expert safety input for product development, launch readiness and lifecycle management.
Promote shared accountability for patient safety across departments.
Qualifications
Advanced degree preferred.
15+ years of pharmacovigilance experience, with at least 10 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 such as Argus or ArisG and PV software tools.
Demonstrated expertise in regulatory compliance, risk management, cross‑functional collaboration and operational excellence.
Additional Information We prioritise diversity, equity and inclusion, creating an equal‑opportunity workplace where people of all cultural backgrounds, genders and ages can grow.
We Offer
Training and career development opportunities internally.
Strong emphasis on personal and professional growth.
A friendly, supportive working environment.
Opportunity to work with colleagues worldwide, with English as the company language.
Core Values
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
#J-18808-Ljbffr
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid‑size pharmacovigilance service provider established in 2008. With a global presence across Europe, North America and Asia, we deliver medical information, pharmacovigilance, regulatory affairs and quality assurance services. We prioritise training and employee development, fostering a healthy work‑life balance and a culture of continuous learning. Our mission is to positively impact patients’ lives through high‑quality safety and regulatory support for pharmaceutical and biotechnology partners.
Job Description The Executive VP, Pharmacovigilance 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 manages PV teams, optimises operational processes and collaborates cross‑functionally to ensure the highest level of patient safety and product quality. Key areas of focus include cost optimisation, speed and quality of delivery informed by metrics.
Leadership & Strategy
Provide strategic direction for PV operations, aligning with corporate goals and regulatory expectations.
Develop comprehensive operational strategies that align with the company’s overall objectives, ensuring long‑term goals are met through efficient processes.
Plan expansion of safety and PV services to drive revenue, operational margins and resource utilisation.
Lead, mentor and develop PV operational teams, fostering accountability and continuous learning.
Partner with Enterprise PMO/BPO to realise the objectives of the Value Creation Plan.
Represent PV operations at senior/executive management meetings, governance boards and cross‑functional leadership forums.
Accurately forecast future resource needs and allocate accordingly.
Define KPIs and monitor team performance.
Operational Excellence
Champion a culture of excellence across global PV operations, embedding best practices, innovation and continuous improvement.
Collaborate with Enterprise PMO/BPO to optimise and standardise end‑to‑end pharmacovigilance processes, ensuring efficient, compliant and high‑quality execution of PV projects.
Streamline workflows, leverage automation and emerging technologies to improve data accuracy, reporting timeliness and decision‑making speed.
Identify optional process variations and engage commercial leadership to maximise revenue opportunities.
Monitor KPIs and performance dashboards to track operational efficiency, compliance metrics and signal detection performance.
Drive global harmonisation of PV processes across regions, affiliates and partners to ensure consistent execution and regulatory alignment.
Lead inspection readiness and quality excellence initiatives, ensuring systems, documentation and processes exceed regulatory expectations.
Integrate safety insights into strategic product lifecycle management through collaboration with Regulatory Affairs, Quality, Medical Affairs and Clinical Development.
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 organisational needs.
Collaborate with Enterprise PMO/BPO to realise the objectives of the Value Creation Plan.
Leverage data analytics and AI‑driven solutions to enhance efficiency, accuracy and scalability.
Streamline workflows to optimise resource allocation, reduce cycle times and strengthen safety data quality.
Implement industry benchmarking and best practices to drive competitive advantage.
Engage Enterprise PMO/BPO to ensure adherence to corporate governance for ongoing change initiatives.
Cross‑Functional Collaboration
Act as a strategic bridge between Pharmacovigilance Operations and key internal stakeholders, ensuring safety intelligence informs corporate decision‑making across the product lifecycle.
Embed PV insights into strategic business planning, ensuring safety, compliance and benefit‑risk considerations are central to portfolio management.
Facilitate global alignment by harmonising safety processes and communications between affiliates, regional offices and headquarters.
Participate in governance committees and safety boards, providing expert safety input for product development, launch readiness and lifecycle management.
Promote shared accountability for patient safety across departments.
Qualifications
Advanced degree preferred.
15+ years of pharmacovigilance experience, with at least 10 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 such as Argus or ArisG and PV software tools.
Demonstrated expertise in regulatory compliance, risk management, cross‑functional collaboration and operational excellence.
Additional Information We prioritise diversity, equity and inclusion, creating an equal‑opportunity workplace where people of all cultural backgrounds, genders and ages can grow.
We Offer
Training and career development opportunities internally.
Strong emphasis on personal and professional growth.
A friendly, supportive working environment.
Opportunity to work with colleagues worldwide, with English as the company language.
Core Values
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
#J-18808-Ljbffr