Full-Time
Associate Pharmacovigilance Project Director
Delivery, Europe
Ergomed
Clinical research and drug safety services
No salary listed
Madrid, Spain
Remote
 Biology & Biotech (1) |
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- Excellent client-facing and internal written and verbal communication skills.
- Varied pharmacovigilance experience in a contract research organization.
- Previous experience within pharmacovigilance project management.
- Organizational skills, including attention to detail and multitasking.
- Management skills, including time and issue management.
- Conflict resolution skills.
- Decision-making skills.
- Teamworking skills.
- Ability to motivate and coach people, demonstrating leadership.
- Ensure that all contracted activities for clients are delivered within budget, on time, with good quality, and in compliance with applicable regulatory requirements.
- Support project teams as a pharmacovigilance expert on contracted client activities as necessary.
- Provide support to department heads and senior leadership on client and company activities as applicable.
- Represent client and company interests with direct reports while maintaining the agreed project scope.
- Oversee changes to project scope, schedule, and costs as applicable.
- Maintain good client relations and consistently high-quality work.
- Participate in issue escalation processes.
- Understand client pharmacovigilance requirements and ensure services address them.
- Oversee and monitor project setup, maintenance, and activity planning; attend client meetings as required.
- Maintain an overview of client deliverables and participate in tasks delivered to the client as applicable.
- Oversee communications with clients regarding issues.
- Oversee training of project teams.
- Coordinate with internal and client departments to ensure contracted activities are delivered with high quality and within timelines.
- Ensure departments and personnel are familiar with the client and project scope.
- Review client-specific core documents, such as joint operational guidelines and safety management plans.
- Ensure invoices are prepared and sent on time.
- Review project-specific analyses as needed.
- Advise clients on pharmacovigilance matters, including regulatory or guidance changes.
- Provide appropriately qualified resources to ensure effective project management and delivery.
- Oversee quality management system activities for the client as required.
- Ensure applicable client quality standards are met.
- Ensure compliance with worldwide pharmacovigilance regulatory obligations; manage quality events and implement corrective and preventive action.
- Participate in client audits and inspections.
Ergomed is a clinical-research and pharmacovigilance services company. Clinical, regulatory, scientific, and technology teams manage studies and safety processes across development programs. It supports biotechnology and pharmaceutical clients with clinical trial delivery, medical information, and drug-safety operations. The scope is Ergomed Group and its CRO and PrimeVigilance businesses. Roles include clinical operations, project management, biostatistics, data management, medical writing, pharmacovigilance, and support functions. Its workforce connects frontline delivery with the specialist, operational, technical, and business teams that support the organization.
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Total Funding
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Headquarters
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Founded
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Simplify's Take
What believers are saying
- Ergomed was named a 2026 Fierce Outsourcing Awards finalist for Clinical Trial Management.
- CTO West Coast 2026 showcased active demand for its oncology CRO team in April 2026.
- Revelio Labs shows Ergomed reaching about 2,510 employees and 157 active jobs in 2026.
What critics are saying
- Permira’s 2023 buyout and delisting force growth targets, leverage discipline, and exit pressure.
- Founder-chair Miroslav Reljanovic’s April 2026 retirement removes the company’s original strategic anchor.
- IQVIA, Syneos, and Labcorp can undercut Ergomed on scale, crushing specialty pricing by 2027.
What makes Ergomed unique
- Ergomed has 500-plus oncology studies, 30,000-plus patients, and 3,800-plus sites worldwide.
- Ergomed focuses on complex oncology, rare disease, and advanced therapies for small biotech sponsors.
- Ergomed’s April 2026 board transition kept CFO Zubair Javeed in interim CEO role.
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Company News
CTO West Coast 2026. Speak with its specialty oncology CRO team about advancing complex clinical trials. Speak with its specialty oncology CRO team about advancing complex clinical trials. Ergomed Clinical Research is a global specialty CRO supporting oncology sponsors with the delivery of complex clinical trials. At CTO West Coast 2026, its team will be available to discuss how Ergomed Group help biotech and pharma companies navigate trial complexity, strengthen execution, and advance development with confidence. From early-phase strategy to global study delivery, Ergomed Group provide flexible, tailored support for challenging oncology programs where operational precision, cross-functional coordination, and patient-focused execution matter most. Meet its experts. Its clinical development and business development team will be available for conversations throughout the event at Booth #24. Meet with Ergomed Group to discuss your upcoming oncology studies, protocol complexity, outsourcing strategy, operational planning, and delivery priorities.
Ergomed Clinical Research Named Finalist in Fierce Outsourcing Awards 2026 for "Clinical Trial Management" Raleigh, N.C., April 15, 2026 - Ergomed Clinical Research Named Finalist in "Fierce Outsourcing Awards for "Clinical Trial Management" Ergomed Clinical Research, a global CRO specializing in the most complex trials, has been named a finalist in the 2026 Fierce Outsourcing Awards in the Clinical Trial Management category. The case-based nominations were evaluated on evidence of strong trial planning, execution, and oversight, along with the ability to demonstrate clear impact on operational efficiency, patient engagement, and study outcomes. This recognition reflects the excellence of Ergomed Clinical Research's delivery in a pivotal multi-country study executed under a fixed seasonal recruitment window and limited on-site monitoring capacity. Ergomed's submission centered on a pivotal Phase III study conducted across Germany, Poland, Bulgaria, Latvia, Lithuania, and Austria. Recruitment could take place only between September and mid-February, creating one narrow execution window. Within that constraint, Ergomed successfully obtained regulatory approval for 102 sites, activated 99 of them, achieving 85% site activation within a three-month timeframe. The study screened 1,180 participants and randomized 692, exceeding the original target of 552 by 25%. Final randomization was completed ahead of plan, and dropout remained at 7.4% versus 15% anticipated. The submission also highlighted Ergomed's Operating Model, the source of excellence by design: disciplined project management, close coordination across start-up, regulatory, clinical operations, data management, biostatistics, and medical operations, RBQM-led centralized oversight, and proactive site management during peak recruitment to resolve supply, ePRO compliance, lab kit, equipment availability, and compliance issues before they slowed site performance. As data cleaning progressed toward database lock, the team closed 54,075 queries while maintaining regulatory and ethical control. "Recognition in this category matters because it reflects execution under pressure," said Natalia Grassis, Chief Clinical Research Services Officer at Ergomed. "The submitted program combined rapid activation, disciplined cross-functional delivery, proactive site support, and continuous oversight. Those are the same fundamentals biotech sponsors need when timelines are fragile and there is little room for operational drift." The operational excellence recognized in this nomination, and reflected in this submission, validates the operating model Ergomed Clinical Research brings to complex trials, particularly those in rare disease and oncology. Excellence by design is the result of realistic recruitment planning, proactive site support, and tight operational control designed to protect timelines and data quality. "This recognition as a finalist reflects the culture we've built together: one that puts patients at the heart of what we do, strives for excellence, and delivers with strong operational discipline," said Jasmina Punek, Chief People Officer, Human Resources at Ergomed Group. To learn more about the study behind this recognition, read the case study that supported Ergomed Clinical Research's nomination for the 2026 Fierce Outsourcing Awards in Clinical Trial Management. About Ergomed Clinical Research Ergomed Clinical Research turns high-stakes study plans into trials that move complex assets forward with speed, precision, and operational control. Ergomed Group is a global, full-service CRO specializing in oncology, rare disease, and other advanced therapies. As a clinical development partner to small and mid-size biotech, Ergomed Group use an agile delivery model to ensure programs start strong, with efficient site activation and patient recruitment, so trials maintain momentum in demanding development settings. Its methodology has been shaped by experience, including 500+ oncology studies, with 30,000+ patients, and 3,800+ sites globally. And its experience has taught Ergomed Group to be obsessed with what matters most: rigorous feasibility and realistic recruitment assumptions; evaluating protocols and operational strategy from the site and patient perspective; quality, transparency, and trust. This is how Ergomed Group protect sponsors' timelines and reduce risk. Media Contact: