Safety Scientist

Roles & Responsibilities: Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available. Manage and maintain Global safety mailbox. May participate in the case narrative generation, review and refinement process depending upon level of experience. Conducts several rounds of query and response (back to site) under the guidance of Medical reviewers to gain complete and accurate case information. Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications. Processes all field and narrative case data entry. Processes all Adverse Effects (AE), medical history and con meds coding. Transfers case to Regulatory Affairs for Submission (if SUSAR) or Final Closure of Case in global database (if not an expedited report). Ensures that all international regulations are followed regarding pharmacovigilance procedures. Perform quality control activities including the review of source documents and case data to verify accuracy and consistency as well as to ensure compliance with timelines and quality standards Participates as a cross functional team member of Study Execution Teams. Participates in Serious Adverse Event (SAE) Reconciliation activities with the SAE information in the clinical trial database. Performs periodic Global Safety Database searches to support inquiries from stakeholders as required. May assists in the creation of ad hoc safety reports for submission to relevant stakeholders both inside and external. Reviews and may be responsible for authoring Standard Operating Procedures (SOPs) and Work Practice Instructions. Reviews all cases for completeness and accuracy of data versus available source documents. Ensures that in all received and created documentation, that patient privacy and confidentiality of identity be maintained and recommends steps that should be taken to avoid or mitigate breaches. Education & Experience: Bachelor’s degree in pharmacy / related field 1 – 2 years of experience in drug safety/regulatory affairs or pharmaceutical domain is required Must be methodical, compliant to processes yet flexible when needed Independent yet able to work cohesively with a team