Safety Reporting Manager, Team Leader

<h3>Company Description</h3><p>We are PrimeVigilance (part of Ergomed Group), 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. </p><p>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. </p><p>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. </p><p>Come and join us in this exciting journey to make a positive impact in patient’s lives. </p><h3>Job Description</h3><ul><li>Manages and mentors the safety reporting staff in the ICSR Management Unit</li><li>Ensures adequate distribution of tasks for assigned safety reporting staff and oversees the workflow process</li><li>Operates as the link between Regulatory Intelligence Department and ICSR Management Unit to ensure accurate guidelines are followed and optimal processes are in place</li></ul><p>ROLE AND RESPONSIBILITIES</p><ul><li>Providing support to activities related to safety reporting undertaken by the project team on behalf of the client and the company</li><li>Reporting Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines</li><li>SAE/SUSAR Reporting Management</li><li>Workflow &amp; resource management</li><li>Line Management tasks (periodic appraisals, performing vacation approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)</li><li>Mentoring and training of new and more junior employees within the department</li></ul><p>Team Leader responsibilities:</p><ul><li>Leads the team responsible for safety reporting</li><li>Leadership and expert advice in the area of safety reporting</li><li>Line management of the assigned team and subordinated colleagues</li><li>Training and development of skills</li></ul><p> </p><h3>Qualifications</h3><ul><li>Life Science Degree</li><li>Demonstrated safety reporting experience </li><li>Strong line management experience</li></ul><h3>Additional Information</h3><p>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.  </p><p>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. </p><p><strong>Our Offer</strong></p><ul><li>Competitive salary</li><li>Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth</li><li>Multicultural environment, English as a company language</li><li>Strong emphasis on personal and professional growth</li><li>Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad</li><li>Friendly working environment with several social events per year</li></ul><p> </p><p>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!  </p><ul><li>Quality </li><li>Integrity &amp; Trust  </li><li>Drive &amp; Passion  </li><li>Agility &amp; Responsiveness  </li><li>Belonging </li><li>Collaborative Partnerships  </li></ul><p>We look forward to welcoming your application. </p><p> </p>