Pharmacovigilance Medical Safety Lead

IQVIA; Bogotá ciudad; Sur place; COP 180 000 000 - 240 000 000; Plein temps

Résumé du poste

IQVIA is seeking an experienced Associate Medical Safety Director to provide medical expertise on pharmacovigilance services across trials and safety projects. You will participate in all safety activities with oversight from management and senior safety directors.

You will review AEs and ADRs, prepare AOSE analyses, and support case processing teams. The role includes regulatory reporting, safety oversight, and client-facing responsibilities.

Qualifications

• Medical degree from an accredited and internationally recognized medical school.
• 7+ years of clinical practice experience: signal management, trial reports, client-facing activities.
• 9+ additional years in the pharmaceutical or related industry.
• Knowledge of federal and local regulations for clinical research including safety/gcp.
• Knowledge of clinical trials and pharmaceutical research process.
• Ability to prioritize, meet deadlines, and achieve objectives.
• Skills in consultation and advisory on multiple assignments, with initiative and flexibility.
• Ability to maintain effective working relationships with coworkers, managers and clients.
• Valid medical license, or equivalent, in the country/region of residence.

Responsabilités

• Perform medical review of trial-related AEs and ADRs including narrative, queries, coding, seriousness, causality and company summary.
• Compose, edit and review AOSE analyses for expedited cases as regulatory requirements dictate.
• Serve as internal consultant to pharmacovigilance case processing teams on projects.
• Provide aggregate safety reviews to maintain oversight of a product’s safety profile.
• Provide coding review of AEs, past medical history, concomitant meds for data vetting.
• Represent safety and clinical data findings in client meetings.
• Provide medical review/edits to regulatory reports (IND annual, EU/US safety reports).
• Provide medical oversight for risk management plans and label development.
• Support Data Safety Monitoring Board meetings and safety committees.
• Ensure deliverables meet timelines and provide medical escalation support when needed.

Connaissances

Medical knowledge

Regulatory knowledge

Communication skills

Client liaison

Formation

Medical degree

Bachelor's Degree in Medicine

Description du poste

IQVIA is seeking an experienced Associate Medical Safety Director to provide medical expertise on pharmacovigilance services across trials and safety projects. You will participate in all safety activities with oversight from management and senior safety directors.

You will review AEs and ADRs, prepare AOSE analyses, and support case processing teams. The role includes regulatory reporting, safety oversight, and client-facing responsibilities.