Associate Medical Safety Director
Contract Type: 12-Month Fixed-Term
Job Overview
The Associate Medical Safety Director provides medical expertise in pharmacovigilance services across clinical trials and post-marketing safety activities. The role involves performing medical safety evaluations, ensuring compliance with regulatory requirements, and supporting safety-related deliverables with appropriate oversight from senior medical safety leadership.
Key Responsibilities
Medical Review & Safety Case Management
Review and clarify trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narratives, queries, coding, expectedness, seriousness, causality, and company summaries.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases per regulatory requirements.
Provide coding review of AEs, past medical history, concomitant medications, and other clinical data listings.
Safety Oversight & Aggregate Review
Conduct aggregate reviews of safety data to monitor and maintain product safety profiles.
Provide medical contributions to Integrated Safety Summaries (ISS) and Common Technical Documents (CTDs).
Review and sign off on Project Safety Plans and Medical Monitoring Plans within contracted scope.
Regulatory & Reporting Support
Review and edit safety sections of:
IND Annual Reports
EU Periodic Benefit Risk Evaluation Reports (PBRERs)
EU Periodic Safety Update Reports (PSURs)
EU Development Safety Update Reports (DSURs)
US Periodic Reports
Review and edit Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
Provide medical review and edits to Drug Safety Reports and other benefit–risk assessments.
Committee & Board Involvement
Provide medical support and participate in Data Safety Monitoring Board (DSMB) meetings.
Attend and contribute to Safety Monitoring Committees.
Act as Global Safety Physician (or Assistant/Backup) for assigned projects.
Provide medical escalation support for EU Qualified Persons for Pharmacovigilance (QPPVs).
Project Support & Escalations
Perform medical review of protocols, Investigator’s Brochures (IBs), and Case Report Forms (CRFs) for safety content and data capture.
Represent safety and clinical data findings in client meetings.
Deliver 24-hour medical support as required for assigned projects.
Required Qualifications & Skills
Education:
Medical Degree from an accredited and internationally recognized medical school.
Valid medical license (or equivalent) in the country of residency.
Experience:
Minimum of 3 years clinical practice experience plus at least 2 years in the pharmaceutical or healthcare industry.
Knowledge & Competencies:
Strong understanding of applicable global, federal, and local regulations and guidelines (e.g., GCP, pharmacovigilance).
Knowledge of clinical trial processes and pharmaceutical R&D lifecycle.
Proven ability to manage multiple assignments, meet deadlines, and adapt to changing priorities.
Strong communication and consultation skills with initiative and flexibility.
Ability to build and maintain effective relationships with colleagues, managers, and clients.
About IQVIA
IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services to the life sciences industry. We deliver integrated insights and intelligent connections that accelerate the development and commercialization of innovative treatments, improving outcomes for patients and populations worldwide.
Learn more at: https://jobs.iqvia.com
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Brazil | Sao paulo |Attica :
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