ERGOMED

Manager

• Strategically support and lead the development of proposals, including support strategy development and leading TCs
• Ensure proposal input obtained from a variety of stakeholders, typically involving contributions from sales, marketing, operational teams, finance, legal and top management
• QC and sense check of stakeholder feedback
• Ensure high quality client-focused proposals, budgets and client grids are delivered for new business opportunities
• Attend department meetings including global RFP Triage, P&C internal meetings, and other adhoc calls
• Support and Participate at Proposals training which includes the onboarding of new staff as well as ongoing training of existing staff as well as personnel outside the P&C team
• Support in activities related to coordination, development, negotiation and execution of client contracts and change orders for key accounts and key opportunities
• Support the development of Standardized procedures on a departmental level, and support in streamlining processes on proposal preparation and efficient turnaround timelines
• Support the development of junior staff by organizing lessons learned and continued education programs to optimize team performance and growth
• Support process improvement initiatives that result in the development of costs and proposals of the highest accuracy and effectiveness
• Ensure Senior Management are appropriately involved in QC and contribution to Key Opportunities and their strategies are effectively communicated to the client
• Ensure continuous departmental process improvements and participate in special projects periodically assigned, in addition to day-to-day duties

Proposals Manager – Pharmacovigilance

Compliance

• Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, quality control (QC), and compilation.
• Provide ad hoc regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle.
• Review and provide linguistic input for local Product Information and Mock-ups.
• Serve as the primary contact point for regulatory affairs (RA) matters with national competent authorities (NCAs) and/or clients.
• Involvement in project management of the network of local contact persons for Regulatory affairs.
• Collect, process, and manage regulatory intelligence to keep the organization informed of key updates and changes.
• Propose marketing authorization strategies tailored to client needs.
• Act as a deputy for the line manager when required, ensuring seamless continuity in leadership and operations.

Senior Specialist, Regulatory Registration and Compliance

Medical writer

• Responsible for medical writing including: PSURs/PBRERs PADERs ACOs DSURs RMPs
• QC and review of all written output from the operations team as required
• Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
• In conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates
• Complete quality documentation of aggregate reports
• Attending kick off meetings with new clients as required
• Attending audits and inspections as required
• Providing aggregate report training

Medical Writer II

• 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.

Specialist, Regulatory & PV Delivery

Business Development Rep

• 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

Senior Business Development Director

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

Senior PV Project Manager

General Counsel

• Provide strategic and operational legal support across the organization
• Ensure compliance with laws and regulations
• Proactively manage legal risk and safeguard the organization’s reputation
• Partner with senior leadership and provide legal guidance
• Develop governance frameworks and business strategy
• Oversee internal governance frameworks and compliance
• Draft, review, and negotiate complex agreements
• Manage disputes and litigation matters
• Act as liaison with external stakeholders
• Guide and mentor junior legal team members
• Monitor legislative and regulatory developments

Senior Legal Counsel

• Provides strategic and operational legal support across the organization
• Ensures compliance with applicable laws and regulations
• Manages legal risk and reputation safeguarding
• Partners with senior leadership and provides expert legal guidance
• Contributes to governance frameworks and business strategy development
• Drafts, reviews, and negotiates complex agreements, contracts, and legal documents
• Oversees disputes and litigation matters
• Acts as a primary liaison with external stakeholders
• Provides leadership in handling complex legal matters

Pharmacist

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps.
• Reconciliation activities for all types of received reports

PV Associate, Pharmacist

Research Analyst

• Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
• Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period
• Trains investigational site staff as necessary
• When applicable, supports preparation of regulatory and / or EC submissions
• Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

Senior Clinical Research Associate

Learning and Development

• Collaborate with subject matter experts across geographies
• Create and update learning materials
• Publish courses on our LMS
• Gather feedback and contribute to the continuous improvement of our training programs
• Design and develop training materials aligned with business objectives, applying instructional design models and adult learning principles
• Create interactive, scenario-based content, original learning materials, and assessments in partnership with SMEs across the organization
• Manage multiple concurrent People Development projects, working with internal stakeholders and external technology partners to implement training priorities on time and to standard
• Gather feedback and evaluating training effectiveness using frameworks such as Kirkpatrick to inform continuous improvement of programs

eLearning Specialist

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
• Being involved in tasks to be delivered to the client, as applicable
• 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

• 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.
• 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.
• Being involved in tasks to be delivered to the client, as applicable.
• Oversight on all issues communication with clients.
• Overseeing training of project teams.
• Provide soft skill and technical skill development to grow the PM team talent.
• Support Business Development by assisting with resource planning.
• Monitor and/or manage assigned studies as needed according to all applicable SOPs, regulations, and guidelines.
• 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 requests from PMs for time off and support Project Management coverage plan.

Proposals Manager – Pharmacovigilance

Senior Specialist, Regulatory Registration and Compliance

Medical Writer II

Specialist, Regulatory & PV Delivery

Senior Business Development Director

Senior PV Project Manager

Senior Legal Counsel

Senior Legal Counsel

PV Associate, Pharmacist

Senior Clinical Research Associate

eLearning Specialist

PV Project Director

PV Project Director

Senior Specialist, Regulatory & PV Network