Patient Safety Associate I (Drug Safety Associate I)
Not Disclosed•Full-TimeRemote
location_onVermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States
Make a Meaningful Impact in Global Patient Safety
At Parexel, we are dedicated to improving patient health worldwide. As a Patient Safety Associate I, you will play a vital role in supporting drug safety, clinical trials, and post-marketing surveillance activities. This position ensures full compliance with regulatory requirements and Standard Operating Procedures (SOPs) while contributing to the development of aggregate reports and study-specific safety documents.
You will be part of a global leader in Clinical Research Organization services, where you can contribute to improving patient safety worldwide while developing your career in pharmacovigilance. The role offers the flexibility to work from home in the US.
About the Role
In this position, you will process Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency. Your day-to-day activities include conducting comprehensive literature searches to identify safety signals, tracking regulatory information updates, and assisting in preparing and executing regulatory submissions. You will also manage Medical and Product Dictionary activities where applicable.
Your work is crucial in maintaining compliance through quality reviews of safety deliverables, generating metrics for safety operations, and investigating late deliverable incidents. You will collaborate with team members to ensure adherence to international and local regulatory reporting requirements, supporting the exchange of safety information between global operations and local safety affiliates.
Work location
Work model: Remote
Vermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States
Montpelier, Vermont
Key Responsibilities
- check_circleProcess Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency
- check_circleConduct comprehensive literature searches and reviews to identify safety signals
- check_circlePrepare medically cohesive case narratives and perform MedDRA coding for safety reports
- check_circleSubmit ICSRs and periodic safety reports to Health Authorities and stakeholders
- check_circleMaintain regulatory submission schedules and ensure adherence to reporting rules
- check_circleManage Medical and Product Dictionary activities and data reconciliation tasks
- check_circleConduct quality reviews of safety deliverables and generate performance metrics
- check_circleResearch and maintain global safety reporting requirements in regulatory intelligence databases
- check_circleSupport aggregate report development and study-specific safety document creation
- check_circleAssist with regulatory submissions including eCTD, renewals, and lifecycle management
Requirements
- verifiedBachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences (or equivalent)
- verified3+ years experience in Drug Safety
- verified2+ years experience in post-marketing
- verifiedExperience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease)
- verifiedProficiency with MS Office
- verifiedVeeva Safety experience preferred
Nice to Have
Preference for those with Veeva Safety experience.
Similar Job Opportunities
Skills, education and keywords
Skills: Drug Safety, Clinical Trials, Post-Marketing Surveillance, Regulatory Requirements, Standard Operating Procedures, Sops, Individual Case Safety Reports, Icsrs, Literature Searches, Signal Detection.
Education: Bachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences or equivalent education/experience.
Frequently asked questions about Patient Safety Associate I (Drug Safety Associate I) at Parexel
What does a Patient Safety Associate I (Drug Safety Associate I) at Parexel do?expand_more
A Patient Safety Associate I (Drug Safety Associate I) at Parexel is responsible for the following: Process Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency; Conduct comprehensive literature searches and reviews to identify safety signals; Prepare medically cohesive case narratives and perform MedDRA coding for safety reports; and Submit ICSRs and periodic safety reports to Health Authorities and stakeholders.
What are the requirements for this Patient Safety Associate I (Drug Safety Associate I) role?expand_more
To qualify for the Patient Safety Associate I (Drug Safety Associate I) at Parexel position, applicants should have: Bachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences (or equivalent); 3+ years experience in Drug Safety; 2+ years experience in post-marketing; Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease); Proficiency with MS Office; and Veeva Safety experience preferred.
Where is the Patient Safety Associate I (Drug Safety Associate I) role at Parexel located?expand_more
Patient Safety Associate I (Drug Safety Associate I) at Parexel is based in Vermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States. This is a remote role.
Is this Patient Safety Associate I (Drug Safety Associate I) job remote, hybrid, or on-site?expand_more
Parexel has listed this Patient Safety Associate I (Drug Safety Associate I) role as remote.
How much experience is required for this Patient Safety Associate I (Drug Safety Associate I) role?expand_more
Patient Safety Associate I (Drug Safety Associate I) at Parexel typically requires 3+ years of relevant experience at the mid level level.
What skills do you need for the Patient Safety Associate I (Drug Safety Associate I) role at Parexel?expand_more
Key skills for Patient Safety Associate I (Drug Safety Associate I) at Parexel include Drug Safety; Clinical Trials; Post-Marketing Surveillance; Regulatory Requirements; Standard Operating Procedures; Sops; Individual Case Safety Reports; and Icsrs.
What education is required for Patient Safety Associate I (Drug Safety Associate I) at Parexel?expand_more
Educational requirements for this role: Bachelor's degree in Life Sciences, Health Sciences, or Biomedical Sciences or equivalent education/experience.
What category does the Patient Safety Associate I (Drug Safety Associate I) role belong to?expand_more
Patient Safety Associate I (Drug Safety Associate I) at Parexel is part of the scientific & qa job category on Recrutus.