Ergomed

Company Description We are PrimeVigilance (part of Ergomed PLC), 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 Position Summary This role requires working as part of the Safety System Administrator Team performing database administration activities; supporting creation and upgrade of database instances; change control and data migration activities; first line user support and troubleshooting; and training users on databases. Principal Responsibilities The Safety System Administrator is primarily responsible for: Maintenance of database libraries Involvement in system validation activities Interrogating the database and generating outputs for internal and client use Training and providing database access to internal and client users Principle Functions For the Client (may include but is not limited to the following) Set up and maintenance of project specific database libraries including: o Products o Licenses o Studies o Reporting destinations Documenting and validating any change to the project specific database Support during legacy data transfer e.g., validation Supporting/providing guidance to the Project Manager / Client / Project Start Up Team during the development of project specific data handling guidelines (to ensure project specific guidelines are necessary and will not impact line listings and report generation) Prepare line listings and tabulations and other database outputs for use in aggregate reports, signal detection, reconciliation and other activities as required Provide case processing metrics required for invoicing (e.g., number of submissions, number of spontaneous vs initial cases processed) Provide database training to clients Providing and documenting client / internal team access upon receipt of an approved access request. For the Company (may include but is not limited to the following) Coordinate user access (including maintenance and revoking access) Maintain database procedures including core data handling conventions Provide database training and certification to PrimeVigilance users Provide user support Involvement in root cause investigation of database related deviations and ensure timely and complete documentation of resulting actions in line with Quality procedures Provide case processing quality and compliance metrics to the Quality Team Identify areas for improvement and address via training, clarifying changes to data handling guidelines, user guides etc. Execute business continuity periodic testing for database failure Ensure that existing software bugs, user requests, changes to regulatory requirements etc., are considered and appropriate changes are made and validated as required Support IT, database vendor and technical colleagues in troubleshooting and implementing software fixes and enhancements as required Other Supportive Responsibilities Assist PrimeVigilance senior management on an as needed basis. Potentially provide chargeable consulting / training activities to clients regarding Argus, and if required LSSMV. Qualifications Educated to degree standard Demonstrated work experience within Argus Safety Systems. 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: 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! We look forward to welcoming your application. 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 Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships

Company Description We are PrimeVigilance (part of Ergomed PLC), 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 Engaging in everyday tasks, working on tickets, and maintaining oversight of personal and group tickets to ensure timely resolution. Closing and meticulously documenting resolutions or workarounds in the internal knowledgebase to facilitate knowledge sharing and improve future problem-solving efficiency. Conducting incident response, including first-line investigation, problem analysis, workaround development, and resolution or progression of IT incidents. Categorising, prioritising, and escalating IT incidents to appropriate resolver groups within Service Level Agreement (SLA) parameters. Performing maintenance of laptops and servers, including user and computer administration tasks to ensure optimal system performance. Managing equipment provisioning, including overseeing the onboarding and offboarding processes to maintain seamless workflow transitions. Developing and implementing proactive measures to prevent recurring issues and enhance overall system stability. Collaborating with cross-functional teams to design and implement IT solutions that align with business objectives and user needs. Mentoring junior team members and providing technical guidance to foster skill development within the IT support team. Creating and maintaining technical documentation, including standard operating procedures and user guides, to ensure consistent support delivery. Monitoring system performance and capacity, proactively identifying areas for improvement and optimisation. Staying abreast of emerging technologies and industry best practices and recommending innovative solutions to enhance the company's IT infrastructure and support capabilities. Training of Ergomed Group personnel on IT procedures as appropriate Qualifications 8 plus years relevant work experience in an IT support position Windows 11 and Windows Server 2019 (and newer versions) Microsoft Exchange 2016 (and newer versions) Microsoft SharePoint Online Administration of Office 365 PowerShell scripting Basic familiarity with IT security concepts, including encryption, IDS, IPS, and disaster recovery Networking skills, encompassing routing, switching, and firewall management 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 Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application!

Company Description We are PrimeVigilance (part of Ergomed PLC), 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. Job Description To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions. To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings To cooperate in the preparation of and provide input in Risk Management Plans Supporting the preparation of responses to regulatory authority requests Signalling Reviewing line listings Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation Evaluating and categorizing possible signals and proposing a course of action Supporting preparation and review of benefit-risk reports Qualifications The PV Physician should be medically qualified as a physician Previous experience in pharmacovigilance Ability to review different aggregate report types including PBRERs and DSURs Expertise in signal detection activities is essential Excellent interpersonal skills Ability to plan, organise, prioritise and execute multiple tasks Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork Communication skills Presentation skills English - advanced (spoken, written) Advanced literacy (MS Office) Additional Information 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 Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application!