Associate Medical Safety Director – Global Pharmacovigilance

IQVIA; Bogotá; On-site; COP 180,000,000 - 300,000,000; Full time

Job summary

IQVIA is seeking an Associate Medical Safety Director to provide medical expertise on pharmacovigilance services across trials and safety projects. The role includes medical review of AEs/ADRs, creating AOSEs, and oversight of safety data with management support.

You will collaborate with pharmacovigilance teams, contribute to regulatory deliverables, and participate in client meetings to ensure compliant safety reporting and risk management across global studies.

Qualifications

• Medical degree from accredited medical school.
• 7+ years of clinical practice in pharmacovigilance activities.
• 9+ years in the pharmaceutical industry.
• Knowledge of federal/local regulations for clinical research, safety, and GCP.
• Knowledge of clinical trials and pharmaceutical research process.
• Ability to set priorities, deadlines, and objectives.
• Strong consultation and advisory skills with initiative and flexibility.
• Ability to collaborate with coworkers, managers and clients.
• Valid medical license for the country/region of practice.

Responsibilities

• Perform medical review and clarification of trial-related AEs and ADRs, including narrative content, coding, seriousness and causality.
• Compose and review AOSEs for expedited cases per regulatory requirements.
• Serve as internal consultant to PV case processing teams.
• Provide aggregate safety data reviews and oversight of product safety profile.
• Provide medical data coding review for AEs, medical history and medications.
• Present safety findings during client meetings.
• Review and edit regulatory safety reports (US/EU) and risk management plans.
• Oversee label development and medical content in regulatory documents.
• Attend Data Safety Monitoring Board and Safety Monitoring Committee meetings.
• Contribute to Integrated Safety Summary and Common Technical Document.

Skills

Analytical thinking

Regulatory affairs

Clinical trial analysis

Client communication

Team collaboration

Education

Medical degree from accredited school

Tools

Pharmacovigilance systems

Job description

IQVIA is seeking an Associate Medical Safety Director to provide medical expertise on pharmacovigilance services across trials and safety projects. The role includes medical review of AEs/ADRs, creating AOSEs, and oversight of safety data with management support.

You will collaborate with pharmacovigilance teams, contribute to regulatory deliverables, and participate in client meetings to ensure compliant safety reporting and risk management across global studies.