ERGOMED

Compliance

• 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 & Pharmacovigilance Specialist

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, (e.g.EC/IRB)
• 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 – Oncology, Neurology

• 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.
• 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.
• 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.
• 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.

Regulatory and Pharmacovigilance Specialist, 2 Years Fixed Term Contract

People Operations

• Supports the Regional Associate Director and Senior Director of People Operations with the implementation of the People Operations strategy and aligns with the company’s objectives and organisation strategy;
• Manages people processes for the full employee lifecycle (including payroll) for designated countries and ensures any changes are reflected accurately in the HR system and other internal tools in a timely manner;
• Review escalations from Regional People Generalist in regards to exit interview data and supports where needed, also supports with onboarding where required;
• Liaise with HR Systems to ensure accuracy of data in the HR system and provide HR metrics as required;
• Support HR stakeholders with end of year cyclical activities ie Merit and Bonus reviews;
• Develop, implement, reinforce, and modify HR policies, programs, and procedures.
• Audit HR policies, programs, and procedures against relevant legislation and best practices and recommends improvements;
• The role may involve the supervision of other staff - to include coaching and training, escalations, performance appraisals and KPIs where applicable;
• Act as a point of contact for initial disciplinary and grievance concerns and general employee relations queries. Support HR management with complex cases where required;
• Work with the business and engage with the wider HR teams and HR COE’s to help implement the overall HR strategic agenda and HR operational plans that drive employee engagement, high performance, wellbeing and ED&I initiatives.

Regional People Advisor – Fluent Japanese

• Supports the Regional Associate Director and Senior Director of People Operations with the implementation of the People Operations strategy and aligns with the company’s objectives and organisation strategy;
• Manages people processes for the full employee lifecycle (including payroll) for designated countries and ensures any changes are reflected accurately in the HR system and other internal tools in a timely manner;
• Review escalations from Regional People Generalist in regards to exit interview data and supports where needed, also supports with onboarding where required;
• Liaise with HR Systems to ensure accuracy of data in the HR system and provide HR metrics as required;
• Support HR stakeholders with end of year cyclical activities ie Merit and Bonus reviews;
• Develop, implement, reinforce, and modify HR policies, programs, and procedures.
• Audit HR policies, programs, and procedures against relevant legislation and best practices and recommends improvements;
• The role may involve the supervision of other staff - to include coaching and training, escalations, performance appraisals and KPIs where applicable;
• Act as a point of contact for initial disciplinary and grievance concerns and general employee relations queries.
• Support HR management with complex cases where required;
• Work with the business and engage with the wider HR teams and HR COE’s to help implement the overall HR strategic agenda and HR operational plans that drive employee engagement, high performance, wellbeing and ED&I initiatives.

Regional People Advisor – Fluent in Japanese

• 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
• With the help of a senior member of the team, develop strategy and manage set up activities
• 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
• 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
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database
• 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

Account Manager

• The Sales Development Account Manager focuses on customer acquisition.
• This position is responsible for searching new potential clients-leads and reaching out to relevant prospects to bring new business opportunities.
• Generate and pre-qualify new leads by using appropriate company resources, programs and tools.
• Research leads and identify relevant prospects through various systems and data pools.
• Approach relevant prospects and generate interest via e-mail or phone call to create new business opportunities.
• Develop pre and post conference mail shots and or follow ups.
• Follow up to Marketing leads generated from Websites for conversion of Hot Leads.
• Support the development of targeted email campaigns in line with the strategic company targets.
• Ensure follow-up by passing leads to appropriate team members with all necessary calls-to-action, dates, complete profile information, sources, etc.
• Follow, communicate and collaborate in different sales or marketing strategies with other team members and other departments.
• Support overall Sales and Business Development team in generating new business and achieving company’s targets and expectations.
• Schedule appointments, attend or present at various meetings as needed.
• Prepare and lead early engagement presentations with clients to facilitate RFPs.
• Meet and exceed quarterly and yearly targets.

Sales Development Account Manager – West Coast

Manager

• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project.
• Develop and maintain a project specific Quality Management Plan.
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client’s QMS are adhered to by the Project.
• Supporting junior members of the team and possible line management responsibilities, involvement in training of employees on client projects.

Client Quality Manager – Pharmacovigilance Services

• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project
• Develop and maintain a project specific Quality Management Plan
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client’s QMS are adhered to by the Project
• Supporting junior members of the team and possible line management responsibilities, involvement in training of employees on client projects

Call Center Representative

• Administer and maintain contact center systems (e.g., ContactQ, ZOOM Call Center, or similar)
• Configure and optimize call flows, IVR menus, queues, and routing strategies
• Monitor system performance and troubleshoot issues to ensure uptime and service quality
• Provide technical support and training for agents, supervisors, and managers on contact center tools
• Develop and maintain real-time and historical performance reports, dashboards, and analytics
• Manage user accounts, security permissions, and profiles
• Collaborate with IT and vendor support teams to resolve escalated issues
• Support implementation of new features, integrations, or upgrades
• Document processes, configurations, and system changes (following GAMP 5 and GxP regulations)
• Ensure compliance with data security, privacy, and regulatory standards

Contact Center Administrator

• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project.
• Develop and maintain a project specific Quality Management Plan.
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client’s QMS are adhered to by the Project.
• Supporting junior members of the team and possible line management responsibilities, involvement in training of employees on client projects

• The Sales Development Account Manager focuses on customer acquisition.
• This position is responsible for searching new potential clients-leads and reaching out to relevant prospects to bring new business opportunities.
• Generate and pre-qualify new leads by using appropriate company resources, programs and tools
• Research leads and identify relevant prospects through various systems and data pools
• Approach relevant prospects and generate interest via e-mail or phone call to create new business opportunities
• Develop pre and post conference mail shots and or follow ups
• Follow up to Marketing leads generated from Websites for conversion of Hot Leads
• Support the development of targeted email campaigns in line with the strategic company targets
• Ensure follow-up by passing leads to appropriate team members with all necessary calls-to-action, dates, complete profile information, sources, etc.
• Follow, communicate and collaborate in different sales or marketing strategies with other team members and other departments
• Support overall Sales and Business Development team in generating new business and achieving company’s targets and expectations
• Schedule appointments, attend or present at various meetings as needed
• Prepare and lead early engagement presentations with clients to facilitate RFPs
• Meet and exceed quarterly and yearly targets