Job Title: Associate Medical Safety Director
Company: IQVIA
Location: Not specified
Job Type: Full-time
Job Overview:
Provide medical expertise in pharmacovigilance services. Participate in trials and standalone safety projects under appropriate oversight.
Key Responsibilities:
Medical Review & Safety Analysis:
Review and clarify Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Compose/edit Analyses of Similar Events (AOSE) for expedited cases
Provide aggregate safety reviews and coding verification for clinical data
Safety Documentation:
Review/edit:
IND Annual Reports
Periodic Safety Reports (EU/US)
Development & Risk Management Plans
Drug Safety Reports
Integrated Safety Summary / Common Technical Document
Oversight & Participation:
Medical review of protocols, CRFs, IDBs
Provide medical support at Safety Monitoring Board and Committee meetings
Sign off on safety and monitoring plans
Act as Global Safety Physician/Assistant or Backup
Ensure timely medical safety deliverables
Leadership & Team Management:
Line manage regional physicians
Participate in Global Medical Safety Management Team
Hold bi-monthly meetings with reports
Ensure employee engagement and communication
Ensure team coverage in absences or transitions
Client & Cross-Functional Collaboration:
Represent safety findings in client meetings
Participate in bid defense, RFPs, RFIs
Collaborate with Business Development
Attend internal/external project and SME meetings
Required Qualifications:
Medical degree from an accredited institution
3 years clinical practice + 2 years pharma/industry experience (or equivalent)
Knowledge of clinical research regulations and safety guidelines
Strong project, team, and financial management skills
Excellent communication, leadership, and decision-making ability
Medical license preferred
Key Skills:
Pharmacovigilance expertise
Medical writing and data review
Regulatory knowledge
Strategic planning and customer focus
Team management and leadership
Conflict resolution and stakeholder communication
About IQVIA:
IQVIA is a global leader in clinical research, healthcare data analytics, and life sciences solutions, driving healthcare innovation and improving outcomes worldwide.
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