Company Description PrimeVigilance (part of Ergomed Group), is a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description The Senior Specialist, Regulatory and PV Network (Delivery) is responsible for developing the strategy based on regulatory requirements and for driving regulatory and PV deliverables based on an established PV and regulatory plan. They also 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. The Senior Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country. Job Responsibilities - 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 Qualifications - Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience - Strong experience within pharmaceutical or CRO industry or Regulatory body - Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency - PV training and/or working experience and other educational or professional background as required locally - Fluent in English, both written and verbal - Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance - Proficiency in German, French, or Italian is a plus but not mandatory - Good planning and organizational skills - Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment - Good attention to detail Additional Information Why PrimeVigilance We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: - Training and career development opportunities internally - Strong emphasis on personal and professional growth - Friendly, supportive working environment - Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! - Quality - Integrity & Trust - Drive & Passion - Agility & Responsiveness - Belonging - Collaborative Partnerships We look forward to welcoming your application. #LI remote - Department: Regulatory and PV Network

JD - Job Description Network Eng Job Description We are seeking a Network Admin Level 3 to join our dynamic IT team. In this role, you will be responsible for Design, Build, Implementation, and L2/L3 support for our network infrastructure, ensuring optimal network performance and uptime. The ideal candidate possesses a strong foundation in networking fundamentals and a keen interest in learning and growing within the field. Responsibilities: - Design, implement, and manage network infrastructure, including FortiGate and Cisco Meraki Suit, including Firewalls & Switches, VPN, SD-WAN Cisco ISE, Aruba Clear Pass, AWS Load Balancers, Cisco & Meraki Wireless LAN Controllers and Access Points. - Monitor and maintain network infrastructure, including FortiGate and Cisco Meraki Suit, including Firewalls & Switches, VPN, SD-WAN Cisco ISE, Aruba Clear Pass, AWS Load Balancers, Cisco & Meraki Wireless LAN Controllers, and Access Points. - Troubleshoot and resolve network connectivity issues, escalating complex problems to higher-level engineers as needed. - Configure and maintain network devices according to established procedures and standards. - Implement network access control policies and procedures to enhance security. - Provide technical support to end-users for network-related issues. - Document network configurations, troubleshooting steps, and resolution processes. - Stay updated on emerging network technologies and industry best practices. Qualifications: - Bachelor’s degree in computer science, Information Technology, or a related field preferred. - Strong understanding of networking fundamentals, including TCP/IP, routing, switching, Firewalls, Cloud technology, and network protocols. - Hands-on experience with FortiGate and Cisco Meraki Suit, including Firewalls & Switches, VPN, SD-WAN Cisco ISE, Aruba Clear Pass, AWS Load Balancers, Cisco & Meraki Wireless LAN Controllers and Access Points. - Knowledge of Network Access Control (NAC) principles and technologies. - Excellent troubleshooting and problem-solving skills. - Strong communication and interpersonal skills. - Ability to work independently and as part of a team. Desired Skills: - Proven L3/L4 Troubleshooting Experience in complex environments. - Experience with Multivendor OEM platforms ( Cisco, Meraki, FortiGate, Zscaler ) design, build, and Implementation. - Experience with cloud networking platforms design and implementation (AWS, Azure). - Proven Experience with network virtualization technologies (SD-WAN, SDN). - Experience with network automation and scripting (Python, Ansible, etc.). - Proven Experience with network DDI solution design and implementation. - Experience with network monitoring and analysis tools. - Experience with scripting languages (e.g., Python, PowerShell). - IT certifications CCNP , NSE 3/4 are a plus.

Perform complex network installations, upgrades, and troubleshooting. Configure and validate infrastructure components, conduct quality assurance, document deployments, and coordinate technical support while guiding technicians during network changes.

Analyze customer connections and network augmentations, develop business cases for efficient solutions, optimize network utilization through forecasting, and collaborate with stakeholders to enhance network planning and customer satisfaction.