Descubre una carrera profesional con un gran propósito

Job Overview
Develop and prepare pharmacovigilance agreements for assigned customers. Prepare pharmacovigilance systems master files under direct supervision. Act as deputy EU- QPPV.

This role will require visits to Health Authorities facilities based on demand, while the rest of the time the role can be performed home-based.

Essential Functions

- Regulatory Liaison:

• Serve as the main contact for Health Authorities, including 24/7 availability for urgent calls.
• Represent the company during pharmacovigilance inspections and audits.
• Ensure timely responses to regulatory requests regarding product safety, risk management, and compliance.
  

- Safety Oversight:

• Maintain awareness of evolving safety profiles and local risk minimization measures.
• Ensure systems are in place for timely collection, reporting, and submission of safety data and periodic reports.
• Communicate emerging safety issues to Health Authorities and the EU QPPV.
  

- Compliance & Documentation:

• Keep up to date with local regulatory requirements and implement necessary measures.
• Manage local pharmacovigilance agreements, system master files, and ensure proper documentation.
• Support audits, inspections, and corrective/preventive actions.

- Collaboration & Reporting:

• Work closely with internal teams (regulatory, clinical, QA) and the EU QPPV.
• Provide regular updates and reports on project metrics and safety activities.
• Contribute to risk management plans, safety update reports, and clinical study protocols as needed.
  

- Additional Duties:

• Support collection and follow-up of safety reports (ICSRs).
• Assist with local compliance interventions and ad-hoc activities related to pharmacovigilance
  

Qualifications
• Bachelor's Degree in health science or related area

• English Advanced, mandatory

• +2 years of previous experience in pharmacovigilance

• Previous experience as local contact for Pharmacovigilance (LQPPV) in Mexico will be highly valued

• Availability to travel to Health Authority facilities in Mexico City.

• Experience with HA inspections, desirable.

• Excellent knowledge of Lifecycle Safety processes.
• Ability to work effectively on multiple projects simultaneously.

• Good communication skills

• Collaborative and autonomous

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