Integrated Resources, Inc ( IRI ) · 17 hours ago
Drug Safety Specialist
Cambridge, MA
Contract
Hybrid
Mid Level
$50/hr - $60/hr
4+ years expIntegrated Resources, Inc (IRI) is seeking a Drug Safety Specialist to manage case processing and quality control of clinical trial ICSR's and postmarket case processing. The role involves ensuring timely case completion for regulatory reporting and collaborating with internal stakeholders.
BiotechnologyHealth CareHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Zainab Jitpurwala
Responsibilities
Triage, Intake, case entry and QC of ICSR's originating from sponsored studies or other assigned cases
Includes narrative writing, MedDRA coding, drafting of follow-up queries and event notifications to internal stakeholders
Perform retrospective quality checks on processed cases
Independently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting
Review and resolution of reconciliation issues between the clinical and safety databases per in collaboration with Data Management
Provide investigation details into late regulatory reporting of CT (Clinical Trials) cases
Qualification
Required
Knowledge of Global and local safety regulations
Excellent written and verbal communication skills
Experience in ICSR processing in safety database systems such as ArisG, Argus and Veeva
Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
Bachelor's degree in science or healthcare related field
4+ years experience in pharmacovigilance
Company
Integrated Resources, Inc ( IRI )
Integrated Resources Inc.
501-1000 employees
H1B Sponsorship
Integrated Resources, Inc ( IRI ) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (5)
2023 (13)
2022 (9)
2021 (25)
2020 (39)
Funding
Current Stage
Late StageRecent News
2025-06-11
2025-06-11
2025-04-14
Company data provided by crunchbase