ERGOMED

Director

• Management and support of a team of Project Managers
• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget and are on time with good quality and in compliance with the applicable regulatory requirements
• Support project teams as PV expert on all contracted activities performed on behalf of PrimeVigilance clients, as necessary
• Providing support to Business Unit Leads, Head of Global PM department and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company
• Together with direct reports representing the client's and PrimeVigilance interests with the aim of keeping the agreed project scope
• Oversee management of changes to the project scope, project schedule and project costs, as applicable
• Maintaining good client relations and ensuring a consistently high quality of work for each client
• Being involved in issue escalation process, as applicable
• Understand client PV requirements and ensure service provided addresses all requirements
• Overseeing and monitoring Project set-up and maintenance activities planning; attending client meetings, as required
• Having an overview of deliverables to the clients
• Oversight on all issues communication with clients
• Overseeing training of project teams
• Close cooperation with other PrimeVigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
• Review of client specific core documents (e.g. Joint operational guidelines, Safety management plan), as applicable
• Making sure invoices are prepared and sent on time
• Review project specific analysis, as needed
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
• Providing the client with appropriate qualified resources to ensure their project is managed and handled effectively
• Overseeing the management of Quality Management System activities for the client, as required
• Making sure that quality standards applicable to the respective client are met
• Ensuring compliance with worldwide PV regulatory obligations; manage the process for Quality Events (QEs) and implement corrective and preventative action (CAPA)
• Participation in client audits and inspections
• Accountable for performance development and career management of Project Managers
• Manage performance and growth opportunities of Project Managers
• Provide soft skill and technical skill development to grow the PM team talent
• Develop career plan and provide coaching and mentoring
• Communicate regularly with Project Managers to ensure their knowledge, understanding, and compliance with assigned project goals and departmental and corporate strategies and objectives
• Support Business Development by assisting with resource planning
• Engaging and coordinating with other line managers across the Project Management department
• Participate with the PrimeVigilance Senior Leadership Team to determine and operationalize corporate strategies and visions for the continued growth of PrimeVigilance
• Participate to the development and implementation of recruiting, interviewing, and hiring strategies
• Conduct new employee orientation and onboarding
• Participate in project review meetings with senior management to ensure areas of development, training needs and coaching are aligned with the business needs
• Monitor and/or manage assigned studies as needed according to all applicable SOPs, regulations, and guidelines
• Assess Project Managers performance and liaise with Director of Projects where required
• Assist project teams with coordination of study activities to ensure project deliverables meet sponsor deadlines and ensure all objectives and expectations are fulfilled
• Work with all operational units to help investigate issues and promote effective resolutions
• Establish strong professional relationships with colleagues by building trust, open communication, and managing day-to-day operational issues
• Provide excellent customer service to both internal and external clients; ensure the same from the Project Managers
• Review and approve weekly timesheets for PrimeVigilance tasks
• Review and approve requests from PMs for time off and support Project Management coverage plan

PV Project Director

People Operations

• Facilitate employee documentation and records in HR systems, compiling reports as needed
• Develop, implement, reinforce, and modify HR policies, programs, and procedures
• Audit HR policies against relevant legislation and best practices and recommend improvements
• Provide advice and assistance to employees and managers on HR policies and programs
• Resolve HR inquiries or escalate to appropriate individuals based on severity
• Supports the Regional People Advisor in talent management programs and special projects
• Facilitate onboarding and offboarding, manage logistics with appropriate teams
• Drafting employment contracts and amendments; support employees and managers in HR-related topics
• Promote HR initiatives to create an efficient workplace
• Administer compensation and benefits plans; ensure accurate information for Payroll and Benefits personnel

Regional People Generalist

Medical Director

• Provides all levels of medical monitoring activities including patient safety surveillance and integrity.
• Included in multi-cross-functional support to the project team in conducting clinical trials
• Could act as the main point of contact with the sponsor as a medical representative
• Coordination and delivery of trainings, supervision, and oversight of Medical Monitors
• Main point of contact and escalation for Medical Monitors
• Participation in the development and revision of Medical Monitoring SOPs
• Assists with the assignment, transitioning, and assimilation of individuals to work as Medical Advisors, Medical Monitors and Study Physicians on project.
• Interacts with other departments to ensure the required quality of service is provided to a sponsor

Medical Director – Senior Medical Monitor, Extensive Oncology Experience Required

Business Development Rep

• Initiates, coordinates and develops strategic plans and sales strategies within a specified region.
• Meets annual sales goals and objectives of a key strategic region.
• To manage the team to identify new business sales opportunities, and to work with the internal PrimeVigilance Team to respond appropriately to any enquiry, For example a Request for Information (RFI) or a Request for Proposal (RFP)
• Establish and maintain regular contact and an excellent rapport with future and current clients.
• Prepare and organize sponsor presentations such as bid defence meetings
• Manage the collection of critical information for proposal preparation
• To support the team to understand the RFI/RFP process and to provide detailed input
• Monitor and track competitor PV activities
• Plan and attend major industrial events and tradeshows as budgeted and required
• Identify new markets and research new business opportunities, identifies likely sales points within a specified territory or accounts
• Coordinate and manage all activities aiming to develop and retain clients
• Collects, compiles, analyses, and presents data related to business development in the region and reports to the VP as required
• Provide input and to actively support the VP
• Encourage open and transparent communication throughout the business development department and the wider organization.
• Provide reports as required for senior management and demonstrate leadership in best reporting practices

Director, Business Development – Pharmacovigilance

Manager

• Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader
• Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
• Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Line Manages assigned ICSR staff
• Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency)
• Proposes process changes to ICSR Operational Lead
• Manages ICSR deviations with ICSR Operational Lead support
• Reviews trackers and timesheet data and ensures accuracy
• Is involved in ICSR processing and 2nd QC of cases
• Operates as the assigned team SME and supports other SMEs

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management Position

• Provides oversight and serves as an escalation point for designated projects
• Accountable for the mentoring and supervision of assigned Project Managers
• Developing successful relationships with customers and clients
• Maintaining relationships with assigned clients to drive increased volume of business
• Identifying opportunities for process improvement and communicating with project teams
• Providing regular feedback to senior management on project status, client satisfaction and staff issues
• Supporting development and updating Ergomed Standard Operating Procedures (SOPs)
• Contributes in qualifying and selection of company vendors

Project Director / Associate Project Director

• The Clinical Team Manager will be responsible for site level operational study management
• The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary
• Verifying and ensuring that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments
• Developing, reviewing and revision of project documents (e.g., clinical monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)
• Initiating corrective / preventative measures – e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc.

PV Project Director

Regional People Generalist

Medical Director – Senior Medical Monitor, Extensive Oncology Experience Required

Director, Business Development – Pharmacovigilance

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management Position

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Project Director / Associate Project Director

Clinical Team Manager – Spanish, LATAM Experience