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Pharmacovigilance Associate/Senior Associate

hace 2 meses

Veracruz, Veracruz-Llave, México Icon A tiempo completo
Job Summary

We are seeking a highly skilled Pharmacovigilance Associate/Senior Associate to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. As a key member of our diverse and dynamic team, you will play a critical role in ensuring the safety of our clients' products.

Key Responsibilities
  • Review and Process Safety Events: You will be responsible for reviewing and processing safety events, including pre-marketing, post-marketing, medical device, and drug-related information, in accordance with assigned tasks and project-specific procedures.
  • Abstract and Article Review: You will perform a review of abstracts and full articles to identify safety information from literature sources for both pre and post-marketed products.
  • Data Listings and Accuracy: You will generate data listings from the safety database and ensure the accuracy of the data.
  • Adverse Event Follow-up: You will complete adverse event follow-up in writing and/or by phone, as required for each client.
  • Safety Tracking Systems: You will provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
  • Clinical and Diagnostic Data Review: You will perform a safety review of clinical and diagnostic data as part of case processing.
  • Safety Management Plan Development: You will be responsible for the effective and efficient development of the Safety Management Plan, including the development of specific processes to ensure consistency within the project.
  • Post-Marketing Safety Activities: You will support the creation of post-marketing safety activities, such as PSMF, RMP, and PBRER.
  • Qualified Person for Pharmacovigilance Support: You will support the Qualified Person for Pharmacovigilance as required.
  • Liaison and Communication: You will liaise with investigational sites, reporters, and/or sponsors as necessary regarding safety issues and communicate effectively with ICON Medical Monitors, project managers, and other departments, as appropriate.
  • Aggregated Safety Reports: You will support the generation of Aggregated Safety Reports, including Development Safety Update Reports, IND Annual Reports, Periodic Safety Update Reports, and other cumulative safety reports, through data retrieval and other assigned tasks.
  • DMC Reviews: You will support interim data analysis for DMC reviews.
  • Safety Database Maintenance: You will effectively maintain the safety database and corresponding entry guidelines, ensuring the quality of data following established quality control processes.
  • SAE/AE Reconciliation Plan: You will support the creation of the SAE/AE reconciliation plan and support SAE reconciliation in accordance with this plan and other project-specific guidelines.
  • Signal Detection and Risk Management: You will support Safety Scientists in signal detection and risk management activities.
  • Consistency and Procedural Issues: You will ensure consistency of plans with client contracts and identify out-of-scope activities promptly and accurately, proposing solutions for procedural and technical issues.
  • Audits and Inspections: You will support audits and inspections as required for assigned projects.
  • Medical Information Inquiries: You will respond and process medical information inquiries, including those related to adverse events and product complaints, for clients' products, as per their agreement with ICON.
Requirements
  • Experience: You should have experience in a Pharmaceutical/CRO environment and at least 1 year of experience in the pharmacovigilance area.
  • Communication Skills: You should have excellent verbal and written communication skills.
  • Attention to Detail: You should be detail-oriented.
  • Language Skills: You should be fluent in written and verbal English.
  • Organizational Skills: You should have excellent organizational and time management skills.
  • Teamwork: You should be able to work effectively independently and within a team environment and across global teams.
What ICON Offers

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 designed to be competitive within each country and 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 maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 or submit a request here.

Interested 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.

Are you a current ICON Employee? Please click here to apply.