Pharmacovigilance Specialist (Operations Specialist 2)

IQVIA; Ciudad de México; A distancia; MXN 549,000 - 825,000; Jornada completa

Descripción de la vacante

A leading global clinical research provider in Mexico is seeking a Pharmacovigilance Specialist for a full-time home-based role. The successful candidate will process safety data, ensure compliance with regulations, and collaborate with various teams. This position requires a Bachelor’s degree in life sciences, advanced English, and up to 5 years of relevant experience, including data entry in Argus.

Formación

• Up to 5 years of relevant pharmacovigilance experience.
• In-depth knowledge of global regulatory requirements.
• Excellent time management skills.

Responsabilidades

• Process safety data in compliance with regulations.
• Perform pharmacovigilance activities and data entry.
• Collaborate with cross-functional teams.

Conocimientos

Pharmacovigilance

Data entry inside Argus

Narrative writing

Attention to detail

Organizational skills

English Advanced

Educación

Bachelor's Degree in life sciences

Herramientas

Microsoft Office

ARGUS Safety Database

Descripción del empleo

Job Overview

This is a full-time, regular, 100% home-based role

Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.

Essential Functions

• Process safety data in compliance with regulations, SOPs, and project requirements.
• Perform pharmacovigilance activities:
• Collect and track Adverse Events (AEs) and endpoint information.
• Determine event status, enter data into databases, code AEs/products, and write narratives.
• Conduct literature searches, quality reviews, reconciliation, and case closure.
• Assess safety data for reportability and ensure timely reporting to regulatory authorities and stakeholders.
• Maintain project documentation, templates, and workflows.
• Monitor project metrics, timelines, and deliverables; provide regular updates to management.
• Ensure compliance with quality standards and project processes.
• Collaborate with cross-functional teams (clinical, data management, project management) and healthcare professionals.
• Participate in client communications regarding day-to-day project activities.
• Train and mentor junior team members; support team development.
• Contribute to process improvements and efficiency initiatives.
• Complete all required training and maintain compliance with SOPs.
• Attend project meetings and provide feedback on operational performance.
• Perform other duties as assigned.

Qualifications

• Bachelor's Degree in life sciences (mandatory)
• English Advanced (mandatory)
• Up to 5 years of relevant pharmacovigilance experience, inclusive of up to 3 years of specific experience in data entry inside Argus and narrative writing inside case processing activities (mandatory)
• In depth knowledge and understanding of applicable ARGUS Safety Database and any other internal/Client applications.
• In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements.
• Excellent organizational skills, time management skills, attention to detail and accuracy.
• Excellent working knowledge of Microsoft Office and web-based applications.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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