Description

• Conduct the review of all domestic and foreign SAE reports for all investigational and post marketed products to make sure all important SAE elements are provided.
• Ensure consistency in initial investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility.
• Draft case narrative for SAE reports and prepare MedWatch, CIOMS, and other forms, as needed.
• Perform quality reviews of completed SAE reports received from contract drug safety vendors (CROs); transmit reports to business partners per timelines in safety data exchange agreements.
• Exercise judgment and apply knowledge of FDA and ICH guidelines and product labeling in performing SAE case assessments of expectedness.
• Generate appropriate queries to sites and/or contract drug safety vendors (CROs) to complete and clarify SAE case information; work with the CRO to determine when cases are complete and ready to close.
• Collaborate with Regulatory personnel to communicate reporting of SAEs requiring expedited submission to Regulatory Authorities and to ensure appropriate reporting is performed per timelines.
• Collaborate with cross-functional teams, Clinical Operations, Data Management and Biostatistics; participate in meetings and teleconferences with cross-functional teams, CROs, and business partners.

• Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed.

• Deliver weekly or monthly metrics to supervisor efficiently, accurately and within agreed-upon timelines. Support supervisor with other SAE reporting and Pharmacovigilance Operations.
• Inform Manager/Director of safety related issues and potential trends and or signals arising from review of pre and post marketed safety data.
• May assist in the preparation of safety sections for regulatory documents and in developing Safety forms, standard operating procedures, and process guidelines.
• May assist in signal detection activities and provide line listings for review.
• Should be able to perform case deletions in the safety system if needed.
• Familiar with SAE reconciliation process.
• Support and participate in audits and inspections, including preparation activities.
• Conducts literature searches to ensure the most current and appropriate literature is cited in the materials and to maintain product expertise.
• Review published scientific literature for ICSRs pertinent to company products

• Bachelor's Degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
• At least five years of progressive drug safety experience in a biotech/pharma company.
• Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
• Experience in SAE case-processing and working with safety databases.
• Basic knowledge of MedDRA coding.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Proficient in MS Office Suite.
• Excellent written and verbal communication skills; fluent in medical terminology.
• Ability to interpret and follow regulatory guidelines.
• Ability to multi-task and balance day-to-day drug safety operations and project work with tight timelines.
• Willing and able to work independently and in a collaborative team setting.