Rising Medical Safety Director

IQVIA

Buenos Aires

On-site

ARS 181,747,000 - 272,620,000

Full time

14 days+

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Job summary

IQVIA is seeking an Associate Medical Safety Director to provide medical oversight of pharmacovigilance services across trials and safety projects. You will review AEs/ADRs, develop AOSE analyses, and support client engagements with safety expertise.

The role requires a medical degree, a valid license, and 7+ years in clinical practice plus 9+ years in pharma. You will collaborate with teams to ensure compliance, quality deliverables, and timely safety reporting.

Qualifications

  • Medical degree from an accredited and internationally recognized medical school; Bachelor's in Medicine required.
  • 7+ years of clinical practice experience including signal management and reports.
  • 9+ additional years in the pharmaceutical or related industry.
  • Knowledge of applicable federal and local regulations for clinical research and safety.
  • Understanding of clinical trials and pharmaceutical research processes.
  • Ability to set priorities, meet deadlines and handle objectives.
  • Capability to provide consultation across multiple assignments with initiative.
  • Ability to work with coworkers, managers and clients effectively.
  • A valid medical license or equivalent in the residing country/region.

Responsibilities

  • Review and clarify trial-related AEs and post-marketing ADRs, including causality and seriousness.
  • Compose and medically review AOSE analyses for expedited cases as required.
  • Serve as internal pharmacovigilance consultant on projects.
  • Provide aggregate safety reviews to oversee product safety profile.
  • Review AEs and data listings for medical vetting of clinical data.
  • Represent safety findings in client meetings.
  • Review and edit safety reports (DSURs, PSURs, RMPs) as needed.
  • Oversee labeling safety content and changes.
  • Attend Data Safety Monitoring Board and Safety Monitoring Committee meetings.
  • Contribute to Integrated Safety Summary or CTD sections and other risk assessments.
  • Sign off on Project Safety Plans and Medical Monitoring Plans.
  • Review protocols, IDBs and CRFs for safety content.
  • Act as Global Safety Physician or backup on projects.
  • Attend project and safety team meetings; ensure timely deliverables.
  • Provide medical escalation support for information projects and EU pharmacovigilance.
  • Provide 24-hour medical support on assigned projects; stay updated on developments.

Skills

Clinical practice
Regulatory knowledge

Education

Medical degree (MD)
Medical license

Job description

IQVIA is seeking an Associate Medical Safety Director to provide medical oversight of pharmacovigilance services across trials and safety projects. You will review AEs/ADRs, develop AOSE analyses, and support client engagements with safety expertise.

The role requires a medical degree, a valid license, and 7+ years in clinical practice plus 9+ years in pharma. You will collaborate with teams to ensure compliance, quality deliverables, and timely safety reporting.

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