ERGOMED

• Prompt and effective communication with MAH and local regulatory authorities as required • Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements • Provision of local regulatory intelligence screening and expert advice for the responsible region(s) • Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations) • Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues • Support with development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations • Perform local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information • Maintain accurate records and documentation at local level • Provide support to the RA & PV Global operations team • Preparation and collection of documentation for submissions to the regulatory authorities • Review and linguistic input on local Product Information and Mock-ups • Ensure compliance with MAH's and PrimeVigilance's procedures • Support audits and Inspections • Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market

• Support the team with administrative tasks, including tracking, data retrieval, planning, document organisation and archiving • Collection and tracking of company documents such as CVs, job descriptions, training records, contact details • Maintaining the KPIs of RA&PV Network and arranging for necessary updates, trouble-shooting etc • Data retrieval and tracking for different purposes • Document maintenance on RA&PV Network common shared area • Organising meetings and teleconferences • Preparing documents’ drafts and/or final lay out, as applicable • Communication with all departments and management team, as applicable • Assisting the organisation of RA&PV Network department • Perform other miscellaneous administrative tasks, as applicable

• Reporting directly to the Chief Data Officer • Drive structured evaluation of IT operating model options — full insource, enhanced hybrid, and full MSP • Develop detailed ROI and cost analysis for approval • Own implementation of the chosen operating model • Conduct hands-on commercial and technical due diligence on incumbent and prospective partners • Establish programme governance immediately upon joining • Secure stakeholder alignment across IT leadership, Finance, HR, Legal, and business unit leads • Produce board-quality business cases, decision papers, and transition plans • Take ownership of IT service delivery quality during the transition period • Assess current service management maturity against ITIL best practices and identify gaps • Drive measurable improvement in key service metrics — SLA attainment, incident resolution times, backlog reduction, and user satisfaction • Define the ITSM tooling strategy and initiate implementation as needed • Ensure service continuity is maintained throughout any operating model transition • Deliver a fully documented target operating model • Define internal IT capability blueprint and sequenced hiring plan • Initiate recruitment for critical internal IT roles; identify high-potential individuals for development • Build team culture, operating norms, and accountability frameworks

• 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.

• 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 • 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 • 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 • Track LCPs' key performance indicators and prepare monthly summary reports

• 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.

• 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.

• 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.

• 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.

• 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.