Senior Associate, Regulatory Intelligence and Analytics

Company DescriptionWe 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 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 DescriptionProvide intelligence on requirements and contribute to the development of the strategy and set upactivities including Regulatory Management Plan, joint operating procedures, POAs and coredocuments.

Support identification of issues. Perform regular screening of regulatory legislative requirements updates and ensure maintenanceof 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 othertools Promptly identify and escalate risk/potential risk to the project team which may jeopardisedeliverables. 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 andinternational levels to ensure smooth and efficient service delivery. Participate in preparation for audits/inspections and provide department representation forassigned projects as required.

QualificationsDegree in Chemistry or Life Sciences, Nursing or equivalent experiencePrevious experience within the pharmaceutical/CRO industry not required, however preferredGood planning and organizational skillsGood written and verbal communication skills to clearly and concisely present informationStrong interpersonal skills in a fast-paced, deadline oriented, and changing environmentGood attention to detailExcellent self-motivation skillsProficiency in English, both written and verbalProficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPointAdditional InformationWhat we offerDiverse tasks - data mining, screenings, analysis, requirements review.

Chance to build a broad and comprehensive knowledge on PhV processes and requirementsChance to expand knowledge on other areas covered by Regulatory and Clinical Delivery department i. e. clinical trials, marketing authorisations, XEVMPD, PV NetworkA role in development of RI processes in a motivating environment