.Company DescriptionPrimeVigilance (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 DescriptionThe Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing 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 Specialist will also act as Local Contact Person for the designated country.Job ResponsibilitiesRole and Responsibilities* Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned ensuring effective and rapid coordination and management of deliverables striving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
* Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs and core documents).
Support identification of issues and corrective actions.
* 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.
* Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
* Provide Clients expertise and guidance at national level.
* Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
* Prepare client's invoices and review/ approve vendors' project invoices.
* Provide support to proposal development and input to budgets, provide department representation to BD meetings as required