Associate Medical Safety Director

IQVIA; Municipio de Esquel; On-site; ARS 136,430,000 - 227,383,000; Full time

Job summary

IQVIA is seeking an Associate Medical Safety Director to provide medical expertise on pharmacovigilance across trials and safety projects. You will lead medical reviews of adverse events, develop AOSEs, and act as a senior consultant to PV teams with oversight from management.

You will review safety data, sign off on regulatory documents, attend safety committee meetings, and support global risk management plans, ensuring adherence to regulatory standards.

Qualifications

• Medical degree from an accredited and internationally recognized medical school.
• 7+ years of clinical practice experience; 9+ additional years in the pharmaceutical industry.
• Knowledge of applicable federal and local regulations and guidelines for clinical research.
• Familiarity with safety and good clinical practice regulations.
• Ability to manage priorities, deadlines and client-facing activities.
• Strong communication and relationship-building with coworkers, managers and clients.

Responsibilities

• Perform medical review of trial-related AEs and post-marketing ADRs, including causality, seriousness and coding.
• Compose and review AOSEs for expedited cases according to regulatory requirements.
• Serve as internal consultant to pharmacovigilance case processing teams.
• Provide aggregate safety data reviews to oversee product safety profiles.
• Review and verify medical data across listings and narratives for accuracy.
• Represent safety findings in client meetings and regulatory submissions.
• Edit medical sections of IND, EU and US safety reports and risk management plans.
• Oversee label development and changes from a medical safety perspective.
• Attend Data Safety Monitoring Board and Safety Monitoring Committee meetings.
• Contribute to Integrated Safety Summary and Common Technical Document.
• Sign off on Project Safety Plans and Medical Monitoring Plans.
• Review protocols, IDBs, and CRFs for safety content and data capture.

Skills

Regulatory knowledge

Clinical trial experience

Client facing

Project management

Medical safety

Education

Bachelor's Degree in Medicine

Job description

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.

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.