Senior Associate/Specialist, Regulatory Intelligence and Analytics
hace 2 semanas
- 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 covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming 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, acknowledging that a healthy work-life balance is critical for employee satisfaction and nurtures an environment for high-quality client service.
Come and join us in this exciting journey to make a positive impact in patients’ 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 planning, organizing, and preparing regulatory deliverables following project, corporate, and industry regulatory strategies.
Role and Responsibilities- Provide intelligence on requirements and contribute to the development of the strategy and setup 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 other tools.
- Promptly identify and escalate risk/potential risk to the project team which may jeopardize 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 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 the performance of vendors to aid their assessment.
- 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 in improving the lives of those around us.
What 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 join
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
We look forward to welcoming your application.
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Regulatory Intelligence and Analytics Specialist
hace 2 semanas
Madrid, Madrid, España Prime Vigilance Ltd A tiempo completoAbout the RoleWe are seeking an experienced Senior Associate/Specialist to join our team in Regulatory Intelligence and Analytics at PrimeVigilance Ltd. The ideal candidate will have a strong background in regulatory affairs, with excellent planning and organizational skills.
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Madrid, España Prime Vigilance Ltd A tiempo completo.Senior Associate/Specialist, Regulatory Intelligence and Analytics Full-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...
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Madrid, España Ergomed A tiempo completo.Senior Associate/Specialist, 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...
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Madrid, España Prime Vigilance Ltd A tiempo completo.Senior Associate/Specialist, Regulatory Intelligence and Analytics Full-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...
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Madrid, España Prime Vigilance Ltd A tiempo completo.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...
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Madrid, España Ergomed A tiempo completo.Senior 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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Madrid, España Ergomed A tiempo completo.Senior 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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Madrid, España Prime Vigilance Ltd A tiempo completo.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...
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Regulatory Intelligence and Analytics Specialist
hace 4 semanas
Madrid, Madrid, España PrimeVigilance A tiempo completoJob Title: Senior Associate/Specialist, Regulatory Intelligence and AnalyticsJob Summary:The Senior Associate, Regulatory Intelligence and Analytics is a key member of our team, responsible for delivering high-quality regulatory intelligence and analytics services. This role requires a strong understanding of regulatory requirements and the ability to...
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Madrid, España Prime Vigilance Ltd A tiempo completoSenior 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...
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Madrid, España Prime Vigilance Ltd A tiempo completoSenior Associate/Specialist, Regulatory Intelligence and Analytics Full-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...
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Regulatory Intelligence Specialist
hace 2 semanas
Madrid, Madrid, España Ergomed A tiempo completoRegulatory Intelligence SpecialistThe Senior Associate, Regulatory Intelligence and Analytics is a key member of the PrimeVigilance team, responsible for delivering high-quality regulatory intelligence and analytics services to our clients. • Provide intelligence on regulatory requirements and contribute to the development of strategic plans. • Ensure...
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Madrid, España Prime Vigilance Ltd A tiempo completoSenior Associate/Specialist, Regulatory Intelligence and Analytics Full-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...
-
Madrid, España Ergomed A tiempo completoSenior Associate/Specialist, 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...
-
Madrid, España Ergomed A tiempo completoSenior Associate/Specialist, 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...
-
Madrid, España Ergomed A tiempo completoSenior Associate/Specialist, 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...
-
Madrid, España Prime Vigilance Ltd A tiempo completoSenior 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...
-
Madrid, 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...
-
Madrid, 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...
-
Madrid, España Prime Vigilance Ltd A tiempo completoSenior 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...
