Senior Associate/Specialist, Regulatory Intelligence and Analytics
Full-time
Department: Regulatory Intelligence and Analytics
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.
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 devices.
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 high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient's lives.
Key Responsibilities: Provide intelligence on requirements and contribute to the development of the strategy and set up activities including Regulatory Management Plan, joint operating procedures, POAs and core documents.Support identification of issues.Perform regular screening of regulatory legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.Provide internal teams with guidance on national requirements.Ensure compliance with company procedures, processes, training records, systems and any other tools.Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.Provide administrative support to BD activities.Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.Participate in preparation for audits/inspections and provide department representation for assigned projects as required.Provide feedback on performance of vendors to aid their assessment.Qualifications: Degree in Chemistry or Life Sciences, Nursing or equivalent experience.Previous regulatory experience within the pharmaceutical/CRO industry.
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