ERGOMED

Clinical Research

• Initiates, coordinates and develops strategic plans and sales strategies within a specified territory or accounts.
• Develop account strategies & implementation plans and expand through accounts
• Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts
• Collect critical information for proposal preparation and provide detailed input and leadership of the proposal process for each opportunity initiated
• Prepare and organize sponsor presentations
• Facilitate the preparedness of the team in attending any client meetings. For example, Capabilities meetings or Bid Defence Meetings (BDM)
• Coordinate and monitor any budget or contract negotiations, post award of any work, within a specified territory or accounts.
• Interact with operations, keeping track of study status for projects with sponsors and help coordinate change orders when notified of a change of scope by operations.
• Establish and maintain regular contact and an excellent rapport with future and current clients.
• Monitor and track competitor CRO activities
• Plan and attend major industrial events and tradeshows

Business Development Director – Clinical Research

Compliance

• Assume leadership and functional representation for projects of medium/high complexity ensuring 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.
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• 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.
• Ensure compliance with company procedures, processes, training records, systems and any other tools
• 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.
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
• Provide training, coaching and mentoring to junior members of staff.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide feedback on performance of vendors to aid their assessment.
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.
• Will be required to line manager for the Manager level position

Senior Manager, Regulatory Intelligence and Analytics

• Assume leadership and functional representation for projects of medium/high complexity ensuring 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.
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• 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.
• Ensure compliance with company procedures, processes, training records, systems and any other tools
• 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.
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
• Provide training, coaching and mentoring to junior members of staff.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide feedback on performance of vendors to aid their assessment.
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.
• May also be required to line manager.

Senior Specialist/Manager, Regulatory Intelligence and Analytics

Senior Specialist – Regulatory Intelligence and Analytics

• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
• Ensure compliance with company procedures, processes, training records, systems and any other tools
• 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
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels

• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• 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
• Ensure compliance with company procedures, processes, training records, systems and any other tools
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.

• Assume leadership and functional representation for projects of medium/high complexity ensuring 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.
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• 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.
• Ensure compliance with company procedures, processes, training records, systems and any other tools.
• 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.
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
• Provide training, coaching and mentoring to junior members of staff.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide feedback on performance of vendors to aid their assessment.
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.
• May also be required to line manager.

Project Manager

• 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.

PV Project Manager

• Assume leadership and functional representation for projects of medium/high complexity ensuring 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
• With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
• Provide 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
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• 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
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Prepare client’s invoices and review/approve vendors’ project invoices
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.
• Act as Local Contact Person for Pharmacovigilance or deputy

Senior Specialist, Regulatory & PV Network

• Provide the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan
• Serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate and industry regulatory strategies
• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
• Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
• Support identification of issues and corrective actions
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables
• Provide Clients expertise and guidance at national level
• Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS
• Prepare client’s invoices and review/ approve vendors’ project invoices
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Participate in preparation for audits/inspections and provide department representation for assigned projects as required
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Communicate suggestions for changes to departmental/company processes/procedures

Regulatory and Pharmacovigilance Specialist – Network

• Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents).
• Support identification of issues and corrective actions.
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports.
• Ensure correct training assignment to and training compliance by the LCPs.
• Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
• Provide Clients expertise and guidance at national level.
• Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
• Prepare client’s invoices and review/ approve vendors’ project invoices.
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
• Track LCPs' key performance indicators and prepare monthly summary reports.
• Provide feedback on performance of vendors to aid their assessment.
• Communicate suggestions for changes to departmental/company processes/procedures.
• May act as Local Contact Person for Pharmacovigilance or deputy

Specialist, Regulatory and Pharmacovigilance Network

Auditor

• Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines
• Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP).
• Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
• Assisting with business development activities

GCP Consultant, GCP Auditor

Risk

• Participating in signal detection activities including set-up
• Reviewing line listings required for preparation of signal detection report
• Drafting complex signal detection reports, including quality control
• Evaluating and categorizing potential signals
• Proposing a course of action whenever a potential signal is identified
• Providing support for preparation of communication with regulatory authorities
• 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

Senior Benefit/Risk Associate

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects of medium/high complexity ensuring 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
• With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
• Provide 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
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• 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
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Prepare client’s invoices and review/approve vendors’ project invoices
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

Senior Regulatory and Pharmacovigilance Specialist

Software Engineer

• Request for Proposal (RFP) Budget Development
• Analyze project specifications and RFP documents to determine Ergomed services
• Support Business Development and internal operational staff in developing questions for clients
• Schedule and lead internal strategy calls
• Produce draft budgets that reflect the scope of work
• Consult with business development, department leaders, and senior management to finalize budgets
• Request quotations from third party vendors and assess them
• Conduct self-QC of deliverables to ensure high quality
• Prepare final client-facing budget documents and submit to Business Development
• Timely updates of Salesforce to reflect RFP status
• Attend project handover meetings to provide summary of budget development strategies.

Business Development Director – Clinical Research

Senior Manager, Regulatory Intelligence and Analytics

Senior Specialist/Manager, Regulatory Intelligence and Analytics

Senior Specialist – Regulatory Intelligence and Analytics

Senior Specialist/Manager, Regulatory Intelligence and Analytics

Senior Specialist/Manager, Regulatory Intelligence and Analytics

Senior Manager, Regulatory Intelligence and Analytics

PV Project Manager

Senior Specialist, Regulatory & PV Network

Regulatory and Pharmacovigilance Specialist – Network

Specialist, Regulatory and Pharmacovigilance Network

GCP Consultant, GCP Auditor

Senior Benefit/Risk Associate

Senior Regulatory and Pharmacovigilance Specialist

Budget Developer