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Associate Medical Safety Director

IQVIA -
Ciudad de México, CDMX

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Información del empleo

Tiempo completo
Hace 5 días

Cualificaciones

Administración de personal
Licenciatura

Descripción completa del empleo

Mexico City, Mexico | Full time | Home-based | 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.

Where you'll work

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

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