Local Contact for Pharmacovigilance with Estonian and English language

hace 2 semanas


Madrid, Madrid, España IQVIA A tiempo completo

Local Contact for Pharmacovigilance with Estonian and English languageAs the Local Contact for Pharmacovigilance, you will act as local contact for Pharmacovigilance for customers requiring the services for their product(s).

This role can be conducted either Home Based / Hybrid / Office based from anywhere in Europe - the choice is yours.


RESPONSIBILITIES

  • Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal products.
  • Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
  • Establish and maintain a thorough understanding of each project's budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates.
  • Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns; communicate and document project issues to project team members and department management in a timely manner;
  • Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.
  • Support pharmacovigilance operations as required.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree in a life-science, medicine, pharmacy or nursing or educational equivalent.· 3 years of prior relevant experience including experience managing clinical trial safety/post-marketing safety; or equivalent combination of education, training and experience.· Excellent written and verbal skills in English (min. C1) and Estonian language (min. C2 / native).

  • In-depth knowledge of applicable global, regional and local regulatory requirements, International Conference on Harmonization (ICH) guidelines, and relevant Standard Operating Procedures (SOPs).
  • Very good knowledge of the pharmacovigilance legal framework in Estonia.
  • Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product.
  • Demonstrate an understanding of compliance and of quality management systems.#LI-Remote #LI-Hybrid #LI-OnsiteIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

Learn more at SummaryLocation:
Tartu, Estonia; Lisbon, Portugal; Warsaw, Poland; Madrid, Spain; Prague, Czech Republic; Barcelona, Spain; Sofia, Bulgaria; Dublin, Ireland; Madrid, Spain; Espoo, Finland; Lisbon, Portugal; Barcelona, Spain; Dublin, Ireland; Bratislava, Slovakia; Warsaw, Poland; Prague, Czech Republic; Bratislava, Slovakia; Sofia, BulgariaType: Full time

  • Madrid, Madrid, España PVpharm A tiempo completo

    PVpharm is searching for Local Contact Persons for Pharmacovigilance in several countries.Job descriptionAs a Local Contact Person for Pharmacovigilance you will be involved with different projects, and will provide your expertise within different areas of Pharmacovigilance.Your activities will be mainly: Act as a Local Contact Person for Pharmacovigilance...


  • Madrid, Madrid, España PrimeVigilance A tiempo completo

    Company DescriptionWe 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 and...


  • Madrid, Madrid, España MSD A tiempo completo

    Job DescriptionAre you a passionate pharmacovigilance professional looking for a leadership role in adverse event management? We are seeking a highly skilled and experienced individual to join our team as a Pharmacovigilance Lead. In this role, you will be responsible for ensuring compliance with local laws and regulations, managing adverse event reporting,...


  • Madrid, Madrid, España resourcing life-science A tiempo completo

    Company DescriptionOur client is currently seeking a Pharmacovigilance Manager in SpainJob OverviewResponsible for designing, implementing, and managing pharmacovigilance strategies and activities.Ensure the safety and compliance of pharmaceutical products.Collaborate with cross-functional teams, regulatory authorities, and external partners to maintain a...


  • Madrid, Madrid, España MRL Consulting Group A tiempo completo

    Pharmacovigilance Physician, Remote Based, SpainA specialist, innovative Pharmaceutical company is expanding their Pharmacovigilance department and seeking to hire an experienced Pharmacovigilance Physician.Responsibilities (include but are not limited to) All aspects of Medical Safety related to developmental and marketed products Medical Review of ICSR's...


  • Madrid, Madrid, España PVpharm A tiempo completo

    Do you want to step up in your career in Pharmacovigilance? PVpharm is searching for an experienced Pharmacovigilance Specialist to provide her/his expertise in our challenging pharmacovigilance projects. You will work with complex projects in collaboration with a multidisciplinary, highly motivated and international team.As a Senior Pharmacovigilance...


  • Madrid, Madrid, España BAXTER A tiempo completo

    This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...


  • Madrid, Madrid, España Page Personnel España A tiempo completo

    Support the GL team: Be in direct contact with Invoice to Pay, Cash to Accounting and Treasury leaders. Organize the accounting closing. Supervise the accounts reconciliation. Support of operational tasks for one group of countries Ensure backup for other key points of contact Be part of continuous improvement of processes Be responsible for KPIs linked to...


  • Madrid, Madrid, España Canterbury English A tiempo completo

    Exciting Opportunity to Teach English and Experience Spanish Culture in MadridAre you a recent college graduate looking for a break before diving into the corporate world? Or, perhaps you're tired of your current job and seeking a new career path in teaching English. Whether you're an experienced English teacher or dreaming of starting a new adventure in ESL...


  • Madrid, Madrid, España Samuels English Centre A tiempo completo

    Samuels English Centre is looking for a English language teacher to teach various levels from young primary to adults. These levels include A1 to C1.A specific knowledge in the Cambridge suite and exams is a must.The ideal pick must be able to work under pressure and be adaptable to change.Cambridge Professional development courses/webinars offered on...


  • Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Johnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid.What you will do: Translation of source documents in local language. Reconciliation activities. Literature search and other related activities. Local archive management, ensuring documents generated in the daily pharmacovigilance...


  • Madrid, Madrid, España PrimeVigilance A tiempo completo

    Company DescriptionWe 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 and...

  • Pharmacovigilance Officer

    hace 2 semanas


    Madrid, Madrid, España PrimeVigilance A tiempo completo

    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...


  • Madrid, Madrid, España J&J Family of Companies A tiempo completo

    Internship Pharmacovigilance WDescriptionJohnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments...


  • Madrid, Madrid, España PrimeVigilance A tiempo completo

    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...


  • Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Johnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid.At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions...


  • Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Johnson & Johnson is currently seeking a pharmacovigilance intern to join our pharmacology department located in Madrid.At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions...


  • Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Join us as a Pharmacovigilance intern to help advance the future of health - and follow a career with purpose.Imagine The Breakthroughs We'll Make TogetherAt Johnson & Johnson, we use technology and the power of teamwork to discover new ways to prevent and overcome the world's the most significant healthcare challenges. Our Corporate, Consumer Health,...

  • Gl with Dutch and English

    hace 2 semanas


    Madrid, Madrid, España Page Personnel España A tiempo completo

    Performing daily and closing accounting activities in Local-GAAP and IFRS-GAAP related to GL general postings, internal accounting postings, inventories, buy backs, fixed assets, payroll or taxes. Consolidation and reporting (Company Data and/or Business Unit Data). Closing tasks with quality and on time for the companies. (Wholesale business). Support...


  • Madrid, Madrid, España Seif English Academy A tiempo completo

    Seif English Academy - A leading English academy located in Gran Vía street, Madrid is looking for a full time Administrative Assistant with some experience in customer service and teaching English as a second language.What we offer: Permanent job contract with between paid holidays. The possibility to consolidate your Spanish level, as the position...