Pharmacovigilance: Medical Safety Associate

IQVIA; Municipio de Esquel; On-site; ARS 136,430,000 - 227,383,000; Full time

Job summary

IQVIA is seeking an Associate Medical Safety Director to provide medical expertise on pharmacovigilance across trials and safety projects. You will lead medical reviews of adverse events, develop AOSEs, and act as a senior consultant to PV teams with oversight from management.

You will review safety data, sign off on regulatory documents, attend safety committee meetings, and support global risk management plans, ensuring adherence to regulatory standards.

Qualifications

• Medical degree from an accredited and internationally recognized medical school.
• 7+ years of clinical practice experience; 9+ additional years in the pharmaceutical industry.
• Knowledge of applicable federal and local regulations and guidelines for clinical research.
• Familiarity with safety and good clinical practice regulations.
• Ability to manage priorities, deadlines and client-facing activities.
• Strong communication and relationship-building with coworkers, managers and clients.

Responsibilities

• Perform medical review of trial-related AEs and post-marketing ADRs, including causality, seriousness and coding.
• Compose and review AOSEs for expedited cases according to regulatory requirements.
• Serve as internal consultant to pharmacovigilance case processing teams.
• Provide aggregate safety data reviews to oversee product safety profiles.
• Review and verify medical data across listings and narratives for accuracy.
• Represent safety findings in client meetings and regulatory submissions.
• Edit medical sections of IND, EU and US safety reports and risk management plans.
• Oversee label development and changes from a medical safety perspective.
• Attend Data Safety Monitoring Board and Safety Monitoring Committee meetings.
• Contribute to Integrated Safety Summary and Common Technical Document.
• Sign off on Project Safety Plans and Medical Monitoring Plans.
• Review protocols, IDBs, and CRFs for safety content and data capture.

Skills

Regulatory knowledge

Clinical trial experience

Client facing

Project management

Medical safety

Education

Bachelor's Degree in Medicine

Job description

IQVIA is seeking an Associate Medical Safety Director to provide medical expertise on pharmacovigilance across trials and safety projects. You will lead medical reviews of adverse events, develop AOSEs, and act as a senior consultant to PV teams with oversight from management.

You will review safety data, sign off on regulatory documents, attend safety committee meetings, and support global risk management plans, ensuring adherence to regulatory standards.