Job Title:
Associate Medical Safety Director (12-Month Fixed-Term Contract)
Employer:
IQVIA
Location:
Budapest
Start Date:
1 October 2025
Closing Date:
31 October 2025
Salary:
Competitive
About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. We connect data, technology, and expertise to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.
🔗 Learn more: https://jobs.iqvia.com
Position Overview:
The Associate Medical Safety Director provides medical expertise in pharmacovigilance services and supports all aspects of Medical Safety activities on assigned trials and standalone safety projects. The role operates under the oversight of senior medical safety directors or management.
Key Responsibilities:
Medical Review and Safety Oversight
Review and clarify trial-related Adverse Events (AEs) and Adverse Drug Reactions (ADRs) for content, coding, seriousness, expectedness, causality, and company summary.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as per regulatory requirements.
Conduct aggregate safety reviews to monitor and maintain oversight of product safety profiles.
Perform coding review for AEs, past medical history, concomitant medications, and other medical data listings.
Regulatory and Reporting Contributions
Provide medical review and editing for reports such as:
IND Annual Reports
EU Periodic Benefit-Risk Evaluation Reports (PBRERs)
EU Periodic Safety Update Reports (PSURs)
EU Development Safety Update Reports (DSURs)
US Periodic Reports
Contribute to Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
Support preparation of Integrated Safety Summaries (ISS) and Common Technical Documents (CTD).
Review and sign off Project Safety Plans and Medical Monitoring Plans.
Consultation and Representation
Serve as an internal medical consultant to pharmacovigilance case processing teams.
Present safety and clinical findings during client meetings.
Participate in Data Safety Monitoring Board (DSMB) and Safety Monitoring Committee meetings.
Provide medical escalation support for EU Qualified Person for Pharmacovigilance (QPPV) projects.
Additional Responsibilities
Review protocols, Investigator’s Brochures (IBs), and Case Report Forms (CRFs) for appropriate safety content.
Act as Global Safety Physician, Assistant, or Back-up on assigned projects.
Provide 24-hour medical support as required.
Required Skills and Qualifications:
Medical Degree from an accredited and internationally recognized medical school.
Valid medical license (or equivalent) in the country of residency.
Minimum 3 years of clinical practice experience plus 2 years in the pharmaceutical or healthcare industry.
Strong understanding of clinical trials, pharmaceutical research processes, and pharmacovigilance regulations (GCP, ICH, and local regulatory standards).
Proven ability to prioritize, meet deadlines, and manage multiple projects effectively.
Excellent consultation, communication, and problem-solving skills.
Ability to collaborate and maintain strong working relationships with coworkers, managers, and clients.
Contract Type:
12-Month Fixed-Term
Application Instructions:
Interested candidates are encouraged to apply through IQVIA’s career portal before the closing date.
🔗 Apply on IQVIA Careers
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China | Quarry Bay |Hubei :
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Canada |Ontario :
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