Graduate Pharmacovigilance Associate

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A world-leading healthcare intelligence and clinical research organization seeks a professional proficient in pharmacovigilance to support safety event reviews. The role involves processing safety events and ensuring data accuracy in various reports. This position offers competitive compensation, benefits, and a nurturing work environment focused on development and well-being.

Serviços

Various annual leave entitlements

A range of health insurance offerings

Competitive retirement planning offerings

Global Employee Assistance Programme

Flexible country-specific optional benefits

Qualificações

• Experience supporting safety intake, assessment, and report to regulatory entity.
• Based in Sao Paulo to assist at offices as needed.
• Applies considerable knowledge of company policies and procedures.

Responsabilidades

• Review and process safety events and medically related information.
• Generate data listings from safety database and maintain project files.
• Respond to medical information inquiries and process received information.

Conhecimentos

Knowledge of pharmacovigilance

Advanced English

Knowledge of computerized information systems

Standard application software

Working in safety databases

Formação académica

Bachelor Degree in health sciences

Descrição da oferta de emprego

Overview

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 development.

Responsibilities

What you will be doing:

• Review and process safety events (premarketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures.
• Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products.
• Participate in the generation of data listings from the safety database and assumes responsibility for accuracy of the data.
• Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
• Perform safety review of clinical and diagnostic data as part of case processing.
• Attend project team meetings and teleconferences as required.
• Perform other activities as identified and requested by management, including but not limited to:
  • Respond and process medical information inquiries, including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON.
  • Receives inquiries via phone, fax or email from consumers or healthcare professionals in support of marketed products; triages the inquiry as a request for medical information, product quality compliant and/or adverse event and processes received information in accordance with project specific instructions.
• Submission of expedited Serious Adverse Event (SAE) reports, Periodic reports, line listings and applicable safety information to clients, Regulatory Authorities, Ethics Committees, investigators, third party vendors, Partners, and ICON personnel, if required & as agreed with client during study set-up, within study specified timelines

Qualifications

You are:

• Bachelor Degree in health sciences.
• Experience supporting safety intake, assessment and report to regulatory entity in Brazil or other countries in LATAM or in a global scope.
• Based in Sao Paulo to be able to assist to the offices as needed.
• Applies considerable knowledge of company policies and procedures.
• Applies knowledge of computerized information systems and standard application software (Windows, MS Office)
• Applies knowledge of working in safety databases
• Applies knowledge in pharmacovigilance.
• Advanced English

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.