Pharmacovigilance Submission Specialist
Há 1 mês
.Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. 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 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 Description Role and Responsibilities Supporting the client in all aspects of safety reporting for aggregate reports and related activities Performing submissions of aggregate reports to all concerned parties Performing and oversight of reporting's of Aggregate reports to Regulatory Authorities (RAs), Ethics Committees (ECs), Institutional Review Boards (IRB) and Investigators Tracking and archiving Aggregate reports submissions and exchanges in Aggregate reports tracker and archive, and Project specific tracker and archive Maintaining and oversight over aggregate and submission tracker eCTD compiling for aggregate reports eCTD sequence submission to clients/relevant regulatory bodies Maintaining Submissions mailbox Supporting the client with EudraVigilance registration and maintenance of EudraVigilance account for client Registration on behalf of client Support in all PV operations associated with safety reporting for aggregate reports and related activities Quality control of daily safety reporting activities Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area Preparing invoice data and data reports on submission and project activities of department Supporting business development activities in department Participating in Audits and Inspections Qualifications Life Science degree Previous experience in PV submissions Strong IT skills- working with electronic databases and systems Excellent communication skills Fluency in English, additional languages are beneficial Organisational skills Additional Information 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
-
Pharmacovigilance Submission Specialist
4 semanas atrás
Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro.We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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...
-
Pharmacovigilance Submission Specialist
3 meses atrás
Lisboa, Portugal Prime Vigilance Ltd Tempo inteiroWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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...
-
Pharmacovigilance Submission Specialist
3 meses atrás
Lisboa, Portugal PrimeVigilance Tempo inteiro**Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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,...
-
Lisboa, Portugal Primevigilance Tempo inteiroCompany DescriptionWe are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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...
-
Pharmacovigilance Specialist Ii
2 meses atrás
Lisboa, Portugal Bausch & Lomb Gmbh Tempo inteiroBausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.Our comprehensive portfolio of over 400 products is fully integrated and built...
-
Junior Pharmacovigilance Specialist
4 meses atrás
Lisboa, Portugal Fortrea - Organic Tempo inteiroAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Market Access and Regulatory Advisor
3 meses atrás
Lisboa, Portugal MCR International Tempo inteiroJLF-2307-152 MARKET ACCESS AND REGULATORY ADVISOR LISBON Purpose of the position: - Responsible for developing, communicating and executing market access strategy with local/regional Business Groups and with Global Regulatory Partners, aligned with the company’s global regulatory strategy. - Prepare all the submission prices dossiers and...
-
Senior Start-up Specialist
4 meses atrás
Lisboa, Portugal Labcorp Tempo inteiroLabcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...
-
Proposal Specialist
1 semana atrás
Lisboa, Portugal Workplace Options Llc Tempo inteiro.Who We Are Founded in 1982, WPO is the largest independent provider of holistic wellbeing solutions. Through our customized programs and comprehensive global network of credentialed providers and professionals, we support individuals to become healthier, happier, and more productive both personally and professionally. Trusted by 51% of Fortune 500...
-
Proposal Specialist
1 semana atrás
Lisboa, Portugal Workplace Options Llc Tempo inteiro.Who We AreFounded in 1982, WPO is the largest independent provider of holistic wellbeing solutions. Through our customized programs and comprehensive global network of credentialed providers and professionals, we support individuals to become healthier, happier, and more productive both personally and professionally. Trusted by 51% of Fortune 500 companies,...
-
Proposal Specialist
1 semana atrás
Lisboa, Portugal Workplace Options Tempo inteiro.Who We Are Founded in 1982, WPO is the largest independent provider of holistic wellbeing solutions. Through our customized programs and comprehensive global network of credentialed providers and professionals, we support individuals to become healthier, happier, and more productive both personally and professionally. Trusted by 51% of Fortune 500...
-
Tenders Specialist
3 meses atrás
Lisboa, Portugal HAYS Tempo inteiroJoin a Diagnostics company who is looking for a Tenders Specialist. Your new company Excellent opportunity to join a Diagnostics multinational company who is hiring a Tenders Specialist for the subsidiary based in Lisbon. Your new role This professional will be responsible for preparation and submission tenders/proposals for Diagnostic / Life Science...
-
Study Start Up Specialist
4 meses atrás
Lisboa, Portugal TFS HealthScience Tempo inteiroTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a** **Study Start Up Specialist - (home...
-
Ra/pv Quality Business Partner
3 meses atrás
Lisboa, Portugal Organon Tempo inteiro**Job Description**: **Position Overview** In this role you will help improve and sustain global and local quality and compliance of regulatory affairs and pharmacovigilance activities for all products within the Organon portfolio of drugs, medical devices, and combination products that are commercialized or in development...
-
Pharmacovigilance Specialist Ii
2 meses atrás
Lisboa, Portugal Bausch & Lomb Gmbh Tempo inteiro.Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and...
-
Tax Specialist
4 meses atrás
Lisboa, Portugal EDP PT Tempo inteiroPaís/região: PT- Cidade: Lisboa- Empresa: EDP GLOBAL SOLUTIONS**EDP** is a global energy company that leads based on the values of Innovation, Sustainability and Humanization. Using the technology of the future we create solutions highly focused on the needs of our people and our customers, never neglecting our role and contribution to society. The...
-
Tax Specialist
4 meses atrás
Lisboa, Portugal EDP, S.A Tempo inteiro**EDP **is a global energy company that leads based on the values of Innovation, Sustainability and Humanization. Using the technology of the future we create solutions highly focused on the needs of our people and our customers, never neglecting our role and contribution to society. The **Record to Report Direction **(R2R) of **EDP Global Solutions SA **,...
-
D2C Ecommerce Specialist
Há 6 dias
Lisboa, Portugal Nestlé Sa Tempo inteiroD2C Ecommerce Specialist Position SnapshotLocation: Lisbon, PortugalCompany: Nestlé Business ServicesFull-time / Hybrid modePosition SummaryAs a D2C E-Commerce Specialist you will act as the primary eCommerce technical partner of brand market Digital & eCommerce expert, to update and maintain at market direction an attractive D2C offer, and actively...
-
D2C Ecommerce Specialist
3 semanas atrás
Lisboa, Portugal Nestlé Sa Tempo inteiroD2C Ecommerce Specialist Position Snapshot Location: Lisbon, PortugalCompany: Nestlé Business ServicesFull-time / Hybrid modePosition SummaryAs a D2C E-Commerce Specialist you will act as the primary eCommerce technical partner of brand market Digital & eCommerce expert, to update and maintain at market direction an attractive D2C offer, and actively...
-
D2C Ecommerce Specialist
3 semanas atrás
Lisboa, Portugal Nestlé Sa Tempo inteiroD2C Ecommerce Specialist Position SnapshotLocation: Lisbon, PortugalCompany: Nestlé Business ServicesFull-time / Hybrid modePosition SummaryAs a D2C E-Commerce Specialist you will act as the primary eCommerce technical partner of brand market Digital & eCommerce expert, to update and maintain at market direction an attractive D2C offer, and actively...