Associate Medical Safety Director

IQVIA; Buenos Aires; On-site; ARS 181,747,000 - 272,620,000; Full time

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

São Paulo, Brazil

Mexico City, Mexico

Buenos Aires, Argentina

Bogota, Colombia

Full time

R1534920

Job Overview

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.

Essential Functions

• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) 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
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Provide medical oversight for label development, review and change
• 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 as assigned
• Attend project meetings, medical safety team meetings, and client meetings as requested
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines
• Provide medical escalation support for medical information projects
• Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects
• 24 hour medical support as required on assigned projects
• Maintain awareness of medical-safety-regulatory industry developments

Qualifications

• Medical degree from an accredited and internationally recognized medical school (Bachelor's Degree in Medicine necessary).
• 7+ years of clinical practice experience: Signal management activities, review clinical trial documents, creation, analysis, and presentation of reports (aggregate reports), client facing activities, risk management.
• 9+ additional years in the pharmaceutical or associated 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
• A valid medical license, or equivalent, from the country or region in which he/she resides and works

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. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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