ERGOMED

Project Manager

• Ensure that projects are delivered on time, within budget, and agreed scope, maintaining the appropriate industry, sponsor and Ergomed quality standards
• Liaise with project team members, provide training where needed and ensure correct allocation to tasks
• Develop, review and edit project plans to assure consistency with goals and milestones
• Organization and facilitation of project meetings related to study activities (study organization, initiation, execution, closure)
• Serve as primary point of contact with sponsor and Ergomed Senior Management on project status
• Represent Ergomed at external meetings, providing liaison with scientific/medical experts in other CRO/Sponsor companies and for committee meetings
• Develop review and edit of relevant SOPs to assure consistency with Regulatory standards and develop study related training programs to support this.
• Contribute to bid defense activities

Project Manager, Senior – Oncology Experience Required

• Ensure that projects are delivered on time, within budget, and agreed scope
• Liaise with project team members, provide training where needed, and ensure correct allocation to tasks
• Develop, review and edit project plans to assure consistency with goals and milestones
• Organization and facilitation of project meetings related to study activities
• Serve as primary point of contact with sponsor and Ergomed Senior Management on project status
• Represent Ergomed at external meetings and provide liaison with scientific/medical experts
• Develop review and edit of relevant SOPs

Senior Project Manager

General

• Assume leadership during study Set-up process ensuring development of start up strategy, effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Serve as main point of contact for all project-specific Study Start-Up activities.
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures.
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
• Prepare, collect, review regulatory information to support regulatory submissions for initial authorization and maintenance, in compliance with all applicable regulations.
• Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation.
• Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information.
• Prepare study team reports or updates regarding status of essential document collection, review and approval.
• Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development on site level (if applicable) and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals.
• Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
• Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study specific RACI (Note: activity supported by other team members as per study contract or study specific RACI; e.g. Legal, CTM, Monitor etc.).
• Assist with feasibility and site identification activities as needed.
• Arrange for and/or review translation of essential documents as required.
• Attend project team meetings and training sessions according to project and/or Sponsor requirements.
• Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study specific guidance.
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.
• Support, mentor and train department staff and new-hires.
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
• Assist with development and implementation of trainings and SOPS/practice improvements.

Study Start Up Specialist

• Acting as the primary contact point for project-related matters
• Managing client’s expectations to make sure the client is satisfied with services
• Preparing project scope and objectives based on the signed agreement
• Project activities planning, including deadlines and interim milestones
• Reporting for the client and the PrimeVigilance management

Associate Pharmacovigilance Project Manager – Europe

• Acting as the primary contact point for project-related matters
• Managing client’s expectations to make sure the client is satisfied with services of PrimeVigilance
• Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance
• Project activities planning, including deadlines and interim milestones
• Reporting for the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.

• Acting as the primary contact point for project-related matters
• Managing client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations.
• Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance.
• Project activities planning, including deadlines and interim milestones
• Reporting for the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as basis for invoicing.

Risk

• Participating in signal detection activities including set-up
• Reviewing line listings required for preparation of signal detection report
• Drafting signal detection reports, including quality control
• Record keeping and maintenance of relevant tracking tools
• Working with other company departments to ensure that signal management is conducted in accordance with relevant PrimeVigilance procedures and regulatory requirements

Benefit/Risk Associate II

• Acting as the primary contact point for project-related matters
• Managing client’s expectations to ensure satisfaction with services
• Preparing project scope and objectives based on signed agreements
• Planning project activities, including deadlines and milestones
• Reporting for the client and PrimeVigilance management, e.g., preparation of monthly reports

• Acting as the primary contact point for project-related matters
• Managing client’s expectations to make sure the client is satisfied with services of PrimeVigilance, and that the work PrimeVigilance delivers meets, or even exceeds, the clients’ expectations
• Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance
• Project activities planning, including deadlines and interim milestones
• Reporting for the client and the PrimeVigilance management, e.g., preparation of Monthly reports, serving as the basis for invoicing.

Medical Director

• Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.
• Manage and develop the PV Medical Writing team, fostering performance, engagement, and professional growth.
• Drive quality, compliance, inspection readiness, and continuous improvement initiatives, including oversight of SOPs, KPIs, audits, and regulatory inspections.
• Provide strategic PV medical writing expertise and subject matter leadership to clients, internal stakeholders, and project teams.
• Support business development activities, including proposals, bid defenses, and client engagements.
• Oversee departmental resources, budgets, and operational performance to ensure efficient service delivery.
• Review regulatory safety responses and contribute to Risk Management Plans, aggregate reports, and other key pharmacovigilance deliverables.
• Build and maintain strong client relationships, ensuring exceptional service and trusted partnerships.
• Represent the organization externally through industry engagement, publications, presentations, and professional development activities.

Senior Director – Medical Writing

• Lead the PV Medical Writing function
• Manage and develop the PV Medical Writing team
• Drive quality, compliance, inspection readiness, and continuous improvement initiatives
• Provide strategic PV medical writing expertise
• Support business development activities
• Oversee departmental resources, budgets, and operational performance
• Review regulatory safety responses

Project Manager, Senior – Oncology Experience Required

Senior Project Manager

Study Start Up Specialist

Associate Pharmacovigilance Project Manager – Europe

Associate Pharmacovigilance Project Manager – Europe

Associate Pharmacovigilance Project Manager – Europe

Benefit/Risk Associate II

Associate Pharmacovigilance Project Manager – Europe

Associate Pharmacovigilance Project Manager – Europe

Associate Pharmacovigilance Project Manager – Europe

Associate Pharmacovigilance Project Manager – Europe

Senior Director – Medical Writing

Senior Director – Medical Writing

Senior Director / Executive Director – Medical Writing

Senior Director – Medical Writing