Graduate Pharmacovigilance Associate

ICON Strategic Solutions; Ciudad de México; Presencial; MXN 334.800 - 446.400; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave entitlements

Health insurance offerings

Retirement planning options

Global Employee Assistance Programme

Flexible optional benefits

Descripción de la vacante

A leading clinical research organization in Mexico City is seeking a Graduate Pharmacovigilance Associate to manage case safety reports and support safety monitoring for clinical trials. The ideal candidate will have a degree in health or life sciences and relevant experience in pharmacovigilance. This role offers a competitive salary and a range of benefits geared towards employee well-being and work-life balance.

Formación

• Relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety.
• Ability to read, write, and speak fluent English and the host country language.

Responsabilidades

• Process individual case safety reports including adverse events.
• Perform consistent coding of diseases and adverse events.
• Submit safety reports to Regulatory Authorities as required.

Conocimientos

Pharmacovigilance experience

Knowledge of medical terminology

Fluent in English

Educación

Bachelor’s degree in health or life sciences

Descripción del empleo

Join to apply for the Graduate Pharmacovigilance Associate role at ICON Strategic Solutions.

As a Graduate Pharmacovigilance Associate you will be joining the world’s largest and most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

• Receives and processes individual case safety reports (ICSRs) including serious adverse events, adverse events of special interest, and suspected adverse drug reactions from clinical trials, spontaneous reports and published reports. This includes tracking of received ICSR, entry of ICSR into company or client safety database and query management.
• Performs consistent coding of diseases, adverse events, and medications according to project-specific coding conventions in the Safety Database.
• Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
• Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement.
• Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.
• Supports interim data analysis for DMC reviews.
• Receives inquiries from consumers or healthcare professionals in support of marketed products; triages the inquiry as a request for medical information, product quality complaint, and/or adverse event; processes received information in accordance with project-specific instructions.

Qualifications

• Bachelor’s degree in a health, life sciences or other relevant field of study.
• The successful candidate will have relevant pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
• All employees must read, write and speak fluent English and the host country language.

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.

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/benefits

ICON is committed 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 to perform the essential functions of a position, please let us know through the form below.

Reasonable accommodations: https://careers.iconplc.com/reasonable-accommodations

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing