Pharmacovigilance Submission Specialist

4 semanas atrás

Lisboa, Portugal Primevigilance 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 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. Why? because 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 join
Quality  Integrity & Trust Drive & Passion Agility & Responsiveness Belonging  Collaborative Partnerships We look forward to welcoming your application.

  • Pharmacovigilance Submission Specialist

    Há 5 dias

    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

    Há 2 dias

    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,...

  • Pharmacovigilance Submission Specialist

    2 semanas atrás

    Lisboa, Lisboa, Portugal Primevigilance 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

    2 semanas atrás

    Lisboa, Lisboa, Portugal PrimeVigilance Tempo inteiro

    Company 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 Submission Specialist

    2 semanas atrás

    Lisboa, 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...

  • Senior Pharmacovigilance Specialist

    2 semanas atrás

    Lisboa, Lisboa, Portugal Med Communications International Tempo inteiro

    Senior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - RemoteLisboa Lisbon, Lisbon, Portugal Senior Pharmacovigilance Specialist - Remote Highlights: Pre and post marketing PV experience PV Planning in clinical trialsRMP writing POSITION SUMMARY The Senior Pharmacovigilance Specialist is a professional with scientific,...

  • Senior Pharmacovigilance Specialist

    2 semanas atrás

    Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

    Senior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - RemoteLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Senior Pharmacovigilance Specialist - RemoteHighlights:Pre and post marketing PV experiencePV Planning in clinical trialsDSUR, PSUR/PBRERRMP writingPOSITION SUMMARYThe Senior Pharmacovigilance Specialist is a...

  • Senior Pharmacovigilance Specialist

    2 semanas atrás

    Lisboa, Lisboa, Portugal Med Communications International Tempo inteiro

    Senior Pharmacovigilance Specialist - RemotePOSITION SUMMARY The Senior Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc...

  • Senior Pharmacovigilance Specialist

    Há 5 dias

    Lisboa, Portugal Med Communications International Tempo inteiro

    .Senior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - RemoteLisboa Lisbon, Lisbon, Portugal Senior Pharmacovigilance Specialist - Remote Highlights: Pre and post marketing PV experience PV Planning in clinical trialsRMP writing POSITION SUMMARY The Senior Pharmacovigilance Specialist is a professional with scientific,...

  • Pharmacovigilance Specialist

    3 semanas atrás

    Lisboa, Portugal Labcorp Tempo inteiro

    **Main Responsibilities**: - Responsible for day-to-day adverse experience case management within the Portugal including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per Client's procedure and country regulations, and health authority submissions of cases in accordance with Global Safety...

  • Pharmacovigilance Specialist

    2 semanas atrás

    Lisboa, Lisboa, Portugal Labcorp Tempo inteiro

    Main Responsibilities: Responsible for daytoday adverse experience case management within the Portugal including case intake and followup activities in accordance with Global Safety procedures, the review of local literature as per Client's procedure and country regulations, and health authority submissions of cases in accordance with Global Safety...

  • Senior Pharmacovigilance Specialist

    Há 5 dias

    Lisboa, Portugal Med Communications International Tempo inteiro

    Senior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - Remote Lisboa Lisbon, Lisbon, Portugal Senior Pharmacovigilance Specialist - Remote Highlights:Pre and post marketing PV experiencePV Planning in clinical trialsRMP writingPOSITION SUMMARYThe Senior Pharmacovigilance Specialist is a professional with scientific,...

  • Senior Pharmacovigilance Specialist

    Há 5 dias

    Lisboa, Portugal Med Communications International Tempo inteiro

    Senior Pharmacovigilance Specialist - Remote Lisboa Senior Pharmacovigilance Specialist - RemoteLisboaLisbon, Lisbon, Portugal Senior Pharmacovigilance Specialist - RemoteHighlights:Pre and post marketing PV experiencePV Planning in clinical trialsRMP writingPOSITION SUMMARYThe Senior Pharmacovigilance Specialist is a professional with scientific, clinical,...

  • Junior Pharmacovigilance Specialist

    3 semanas atrás

    Lisboa, Portugal Fortrea - Organic Tempo inteiro

    As 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...

  • Junior Pharmacovigilance And Regulatory Affairs

    4 semanas atrás

    Lisboa, Portugal Buscojobs PT C2 Tempo inteiro

    Your new company Multinational company in health area. Your new position Pharmacovigilance: - Post-marketing safety case handling; - Literature review (of the results sent by the external vendor); - Monitoring of regulatory submissions PV related; - Submission of PV clinical documentation to CA (SUSAR reports and DSURs); - Elaboration of SUSAR line...

  • Junior Pharmacovigilance And Regulatory Affairs

    4 semanas atrás

    Lisboa, Portugal Buscojobs PT C2 Tempo inteiro

    Your new company Multinational company in health area. Your new position Pharmacovigilance: - Post-marketing safety case handling; - Literature review (of the results sent by the external vendor); - Monitoring of regulatory submissions PV related; - Submission of PV clinical documentation to CA (SUSAR reports and DSURs); - Elaboration of SUSAR line...

  • Junior Pharmacovigilance And Regulatory Affairs

    Há 4 dias

    Lisboa, Portugal Hays Tempo inteiro

    Descrição da Função Your new company Multinational company in health area.  Your new position Pharmacovigilance: - Post-marketing safety case handling; - Literature review (of the results sent by the external vendor); - Monitoring of regulatory submissions PV related; - Submission of PV clinical documentation to CA (SUSAR reports and DSURs); -...

  • Market Access and Regulatory Advisor

    2 meses atrás

    Lisboa, Portugal MCR International Tempo inteiro

    JLF-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...

  • Market Access and Regulatory Advisor

    2 semanas atrás

    Lisboa, Lisboa, Portugal MCR International Tempo inteiro

    JLFMARKET ACCESS AND REGULATORY ADVISORLISBONPurpose 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 pharmacoeconomic justification for...

  • Senior Start-up Specialist

    3 semanas atrás

    Lisboa, Portugal Labcorp Tempo inteiro

    Labcorp 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...