Executive Vice President, Pharmacovigilance Operations

PrimeVigilance; Frankfurt; Vor Ort; EUR 120.000 - 160.000; Vollzeit

Zusammenfassung

A leading pharmacovigilance service provider is seeking an Executive Vice President to lead global pharmacovigilance operations in Frankfurt. The role requires 15+ years of experience with operational leadership and a strong background in regulatory compliance and risk management. The ideal candidate will drive strategic initiatives, foster a culture of excellence, and enhance patient safety. Excellent communication and project management skills are essential.

Leistungen

Training and career development opportunities

Friendly working environment

Supportive team culture

Qualifikationen

• 15+ years of pharmacovigilance experience, with at least 10 years in an operational leadership role.
• In-depth knowledge of global PV regulations and drug safety principles.
• Proven track record in managing PV operations in a global environment.

Aufgaben

• Lead and oversee all operational aspects of global pharmacovigilance activities.
• Develop comprehensive operational strategies to align with corporate goals.
• Optimize operational frameworks through process mapping and automation.

Kenntnisse

Leadership

Strategic thinking

Project management

Communication

Regulatory compliance

Ausbildung

Advanced degree

Tools

PV software tools

Argus

ArisG

Jobbeschreibung

Executive Vice President, Pharmacovigilance Operations

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Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid‑size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia covering services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well‑being and mental health and acknowledge that a healthy work life balance is a critical factor for employee satisfaction and nurtures an environment in which a high‑quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s 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. The role manages PV teams, optimises operational processes, and collaborates cross‑functionally to ensure the highest level of patient safety and product quality. The focus is to optimise cost, speed and quality of delivery through metrics that inform management interventions.

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.
• Develop and implement strategic plans for expanding the Safety and Pharmacovigilance services in terms of revenue, operational margins and resources.
• Lead, mentor, and develop PV operational teams, fostering a culture of accountability, high performance, and continuous learning.
• Partner with the Enterprise PMO/BPO to realise 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, ensuring projects have the necessary resources for maximum efficiency and productivity.
• 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 optimise and standardise end‑to‑end pharmacovigilance processes, ensuring efficient, compliant and high‑quality execution of PV project management, case processing, literature, medical scientific affairs, PV regulatory and PV medical information.
• Optimise operational frameworks by streamlining workflows, leveraging automation and integrating emerging technologies to improve data accuracy, reporting timeliness and decision‑making speed.
• Identify optional process variation and engage with commercial leadership to maximise revenue for these options.
• Collaborate with Enterprise PMO/BPO to monitor KPIs and performance dashboards to proactively 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 that PV systems, documentation and processes exceed regulatory expectations and withstand scrutiny from health authorities.
• Foster cross‑functional collaboration with Regulatory Affairs, Quality, Medical Affairs, and Clinical Development to integrate safety insights into strategic 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 organisational needs.
• Partner with the Enterprise PMO to realise the objectives of the value creation plan (VCP).
• Collaborate with Enterprise PMO/BPO to lead the transformation of PV processes through the adoption of automation, advanced analytics and AI‑driven solutions to enhance efficiency, accuracy and scalability.
• Streamline workflows and eliminate redundancies to optimise resource allocation, reduce cycle times and strengthen safety data quality.
• Leverage industry benchmarking and best practices to identify and implement process enhancements that drive competitive advantage.
• Implement robust change management strategies to ensure successful integration of new tools, systems and methodologies across global PV teams and partners.
• Engage with Enterprise PMO/BPO to ensure adherence to corporate governance for the initiation of new and ongoing change initiatives.

Cross‑Functional Collaboration

• Act as a strategic bridge between Pharmacovigilance Operations and key internal stakeholders, ensuring safety intelligence informs and enhances corporate decision‑making across the product lifecycle.
• Embed PV insights into strategic business planning, ensuring that patient safety, compliance and benefit‑risk considerations are central to portfolio management and market expansion decisions.
• Facilitate global alignment by harmonising safety processes and communications between affiliates, regional offices and headquarters.
• Contribute to cross‑functional governance committees and safety boards, providing expert safety input for product development, launch readiness and lifecycle management.
• Promote a culture of shared accountability for patient safety, enabling 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 and process improvement.
• Regulatory compliance and risk management.
• Cross‑functional collaboration.
• High attention to detail and analytical skills.

Additional Information

We prioritise diversity, equity and inclusion by creating an equal‑opportunity workplace and a human‑centric environment where people from all cultural backgrounds, genders and ages can contribute and grow.

We Offer

• Training and career development opportunities internally.
• Strong emphasis on personal and professional growth.
• Friendly, supportive working environment.
• Opportunity to work with colleagues based all over the world, with English as the company language.

Core Values

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

Seniority level

Executive

Employment type

Full‑time

Job function

Management and Manufacturing

Industries

Pharmaceutical Manufacturing

Location

Frankfurt am Main, Hesse, Germany

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