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Urgent! Associate Medical Safety Director (a 12-month fixed-term contract) Job Opening In Budapest – Now Hiring IQVIA
Provide medical expertise on pharmacovigilance services to divisions as requested.
The Associate Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors.
Associate Medical Safety Director (a 12-month fixed-term contract)
Main Responsibilities
• Perform medical review and clarification of trial-related Adverse Events and post-marketing adverse drug reactions including narrative content, queries, coding, expectedness, seriousness, causality and company summary
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile.
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data.
• Represent safety and clinical data review findings during client meetings.
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports.
• Review and edit Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies.
• Provide medical support and attendance at Data Safety Monitoring Board Meetings.
• Attends and contributes medical safety evaluation on Safety Monitoring Committees.
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document.
• Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments.
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract.
• Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
• Act as Global Safety Physician or Assistant or Back-up on projects.
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24 hour medical support as required on assigned projects.
Required Skills and Qualifications
• A Medical Degree from an accredited and internationally recognized medical school.
• A valid medical license, or equivalent, from the country of residency.
• A minimum of 3 years of clinical practice experience with two additional years in the pharmaceutical or health care industry.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice.
• Knowledge of clinical trials and pharmaceutical research process.
• Ability to establish and meet priorities, deadlines, and objectives.
• Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
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Unlock Your Associate Medical Potential: Insight & Career Growth Guide
Real-time Associate Medical Jobs Trends in Budapest, Hungary (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Associate Medical in Budapest, Hungary using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 268 jobs in Hungary and 228 jobs in Budapest. This comprehensive analysis highlights market share and opportunities for professionals in Associate Medical roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! IQVIA is currently hiring and seeking a Associate Medical Safety Director (a 12 month fixed term contract) to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at IQVIA adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Associate Medical Safety Director (a 12 month fixed term contract) Jobs Hungary varies, but the pay scale is rated "Standard" in Budapest. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Associate Medical Safety Director (a 12 month fixed term contract) typically include Other Healthcare Practitioners And Technical Occupations and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your Associate Medical Safety Director (a 12 month fixed term contract) interview at IQVIA, research the company, understand the job requirements, and practice common interview questions.
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