Associate Medical Safety Director

IQVIA LLC; São Paulo; On-site; BRL 300,000 - 380,000; Full time

Job summary

IQVIA LLC is seeking an Associate Medical Safety Director to provide medical expertise on pharmacovigilance services across trials and standalone safety projects. You will participate in all safety activities with oversight from management, ensuring high-quality reviews and regulatory compliance.

You will lead medical review of AEs/ADRs, prepare AOSE analyses, and act as a consultant to PV teams, contributing to DSUR/PSURs and safety documentation while engaging with clients and internal

Qualifications

• Medical degree from an accredited medical school and licensure to practice.
• 7+ years of clinical practice with signal management and trial review.
• 9+ years in the pharmaceutical or related industry.
• Knowledge of safety regulations and GCP across trials.
• Ability to manage priorities, meet deadlines and collaborate.
• Strong consultancy skills for cross-functional projects.

Responsibilities

• Perform medical review of trial-related AEs and post-marketing ADRs with narrative, coding, and causality assessment.
• Compose and review AOSE analyses for expedited cases per regulatory requirements.
• Serve as internal consultant to PV case processing teams.
• Provide aggregate safety reviews to oversee product safety profiles.
• Review and code safety data listings to ensure data integrity.
• Present safety findings in client meetings and regulatory discussions.
• Contribute to safety reports (DSUR/PSURs/ISRs) with medical edits.
• Participate in Data Safety Monitoring Board meetings and safety committees.
• Oversee label development discussions and related safety content.
• Ensure timely delivery of medical safety deliverables per contract timelines.

Skills

Medical safety

Pharmacovigilance

Medical review

Regulatory knowledge

Client facing

Project management

Communication

Team collaboration

Education

Medical degree (MBBS/MD)

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.

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.