Senior Associate/Specialist, Regulatory Intelligence and Analytics
hace 5 días
Senior Associate/Specialist, Regulatory Intelligence and AnalyticsFull-timeDepartment: Regulatory Intelligence and AnalyticsWe 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.The Senior Associate, Regulatory Intelligence and Analytics is responsible for completing regulatory deliverables based on an established 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.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.Good planning and organizational skills.Good written and verbal communication skills to clearly and concisely present information.Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment.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. 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 joinQualityIntegrity & TrustDrive & PassionAgility & ResponsivenessBelongingWe look forward to welcoming your application.
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España Ergomed A tiempo completoSenior Associate/Specialist, Regulatory Intelligence and AnalyticsWe 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...
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España PrimeVigilance A tiempo completoCompany Description 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...
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