Medical Reviewer Ii

Há 1 mês


Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

We are PrimeVigilance (part of Ergomed Group), 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.
Job Description For the Client:
To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues.
To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy.
To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings.
To cooperate in the preparation of and provide input in Risk Management Plans.
Supporting the preparation of responses to regulatory authority requests.
Signalling.
Reviewing line listings.
Participating in signal detection activities including meetings, writing signal detection reports if applicable and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation.
Evaluating and categorizing possible signals and proposing a course of action.
Supporting preparation and review of benefit-risk reports.
Qualifications The PV Physician should be medically qualified as a physician.
Previous experience in pharmacovigilance.
Ability to review different aggregate report types including PBRERs and DSURs.
Expertise in signal detection activities is essential.
Excellent interpersonal skills.
Ability to plan, organise, prioritise and execute multiple tasks.
Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork.
English - advanced (spoken, written).
Advanced literacy (MS Office).
Additional Information Why PrimeVigilance
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
Come and join us in this exciting journey to make a positive impact in patient's lives. We look forward to welcoming your application.

#J-18808-Ljbffr



  • Lisboa, Lisboa, Portugal Primevigilance Tempo inteiro

    We are PrimeVigilance, a leading mid-size pharmacovigilance service provider. Our team is dedicated to delivering first-class support to pharmaceutical and biotechnology partners worldwide.As a Medical Reviewer II Specialist, you will play a crucial role in maintaining long-lasting relationships with our clients by reviewing and approving post-marketing...

  • Medical Reviewer Ii

    2 meses atrás


    Lisboa, Portugal PrimeVigilance Tempo inteiro

    **Company Description** We are PrimeVigilance (part of Ergomed Group), 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,...

  • Medical Reviewer Ii

    2 semanas atrás


    Lisboa, Portugal Primevigilance Tempo inteiro

    We are PrimeVigilance (part of Ergomed Group), 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...

  • Medical Reviewer Ii

    Há 1 mês


    Lisboa, Portugal Primevigilance Tempo inteiro

    Company DescriptionWe are PrimeVigilance (part of Ergomed Group), 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...

  • Medical Reviewer Ii

    Há 1 mês


    Lisboa, Portugal Primevigilance Tempo inteiro

    Job Description For the Client: To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment.The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.To act as a...


  • Lisboa, Lisboa, Portugal Icon Plc Tempo inteiro

    At ICON Plc, we're seeking a Medical Research Nurse Reviewer to join our team. This role is based in Ireland but open to candidates from other European countries who can work from home or office.We're proud to be a world-leading healthcare intelligence and clinical research organization that fosters an inclusive environment driving innovation and...

  • Medical Writer Ii/Iii

    4 meses atrás


    Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    .Medical Writer II/III (aggregate report experience required)Full-timeDepartment: Medical WritingWe 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...

  • Medical Writer Ii/Iii

    4 meses atrás


    Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    .Medical Writer II/III (aggregate report experience required) Full-time Department: Medical Writing 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...

  • Medical Writer Ii/Iii

    4 meses atrás


    Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    Medical Writer II/III (aggregate report experience required)Full-timeDepartment: Medical WritingWe 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...


  • Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    PrimeVigilance Ltd is a global leader in pharmacovigilance service provision, with expertise spanning medical information, regulatory affairs, and quality assurance. We are proud to have achieved organic growth year after year, with staff based across Europe, North America, and Asia.The Medical Writer II/III position offers a unique opportunity to develop...

  • Medical Writer Ii/iii

    4 meses atrás


    Lisboa, Portugal PrimeVigilance Tempo inteiro

    **Company 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...

  • Medical Writer Ii

    6 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 ICON Plc Tempo inteiro

    Clinical Nurse Reviewer I - Ireland but will consider other countries in Europe - Home or office based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical...

  • Medical Reviewer I

    6 meses atrás


    Lisboa, Portugal PrimeVigilance Tempo inteiro

    **Company Description** We are PrimeVigilance (part of Ergomed PLC), 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...


  • Lisboa, Portugal Fortrea 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. Conducting operations in...

  • Medical Safety Specialist II

    4 semanas atrás


    Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    We are PrimeVigilance, a leading mid-size pharmacovigilance service provider. Our company has 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.Our team provides first-class support to pharmaceutical...

  • Digital Content Reviewer

    1 semana atrás


    Lisboa, Lisboa, Portugal Randstad Ii - Prestação De Serviços, Limitada Tempo inteiro

    Job Title: Digital Content Reviewer - Italian Fluency Required">We are seeking a highly skilled Digital Content Reviewer to join our team in Lisbon, Portugal. As a content reviewer, you will be responsible for reviewing apps' content on one of America's biggest technological companies' store.">About the Role:">As a Digital Content Reviewer, you will play a...

  • Clinical Nurse Reviewer I

    4 semanas atrás


    Lisboa, Portugal Icon Plc Tempo inteiro

    Clinical Nurse Reviewer I - Ireland but will consider other countries in Europe - Home or office basedICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical...

  • Clinical Nurse Reviewer I

    4 semanas atrás


    Lisboa, Lisboa, Portugal Icon Plc Tempo inteiro

    Clinical Nurse Reviewer I Role OverviewAt ICON Plc, we are seeking a highly skilled Clinical Nurse Reviewer I to join our dynamic team. As a key member of our clinical review team, you will play a pivotal role in ensuring the quality and integrity of clinical trial data.About the JobThe successful candidate will be responsible for conducting comprehensive...

  • Medical Writing Expert

    4 semanas atrás


    Lisboa, Lisboa, Portugal Prime Vigilance Ltd Tempo inteiro

    Company OverviewPrimeVigilance Ltd is a specialist pharmacovigilance service provider established in 2008. The company has 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.SalaryWe offer an...