Job Details
Posted 15 October, 2026
Job Id: 631738
Sr. Safety Associate
Job Description
Pay Range: $50-60/hr
*depending on experience
Job Scope: Responsible for case processing and/or QC of clinical trial ICSRs and postmarket case processing from sanctioned countries.
Key Responsibilities:
* Triage, Intake, case entry and QC of ICSRs originating from Biogen 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 cases
Essential Skills and Qualifications 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
Education and Experience Requirements for Job:
Education : Bachelors degree in science or healthcare related field
Experience : 4+ years experience in pharmacovigilance
(No Value)
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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