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| | Related Resumes Operations Specialist 2 (Senior Safety Reporting Specialist) Raleigh, NC Clinical Trial Manager, Clinical Trial Coordinator, Clin Trial L Wake Forest, NC Clinical Research Data Entry Durham, NC Medical Review, Pharmacovigilance, Drug Safety Raleigh, NC Clinical Research Associate Raleigh, NC Clinical Research Patient Care Cary, NC North Carolina Clinical Research Durham, NC |
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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLESUMMARYSeasoned Drug Safety Operations professional with many years of experience in Clinical Trials and Pharmacovigilance. Expert in regulatory compliance, safety database management and vendor oversight, with a proven track record in drug safety leadership roles. Skilled in cross-functional collaboration, safety reporting, and process improvement with top biotech and pharmaceutical organizations. PROFESSIONAL EXPERIENCEAmgen, Thousand Oaks CASenior Associate, Clinical Safety Operations Oversee Clinical Safety Operations, ensuring adherence to regulatory standards and data integrity between electronic data capture (EDC) and the global safety database (GSD). Manage vendor activities including training programs to guarantee the delivery of high-quality individual case safety reports (ICSRs). Conduct daily generation of GSD reports to monitor case statuses, queries, and submission activities, maintaining rigorous oversight of ongoing clinical trials. Contribute to the creation and upkeep of essential safety documents such as serious adverse event(SAE) forms, pregnancy documentation and Safety Monitoring plans for designated studies. Beacon Hill Staffing Group, Chicago ILPV Operations Associate Conducted thorough reviews of clinical trial cases to ensure medical accuracy and adherence to regulatory standards, completing serious adverse event reconciliations. Served as the primary liaison between vendors and cross functional teams, facilitating communication and compliance throughout study execution. Managed and maintained project specific safety documentation on SharePoint, upholding organizational standards and facilitating efficient information sharing. IQIVA Biotech, Durham, NCAssociate Safety Reporting Manager Ensured adherence to FDA EU ICH, and GCP guidelines by aligning safety reporting processes with regulatory requirements. Compiled and submitted EudraVigilance documentation for suspected adverse reaction cases during clinical trials. Provided detailed analyses for delayed regulatory reports and responded to inquiries from regulatory authorities. Supported compliance through participation in audits and quality control of safety submissions while mentoring teams to maintain reporting schedules.Senior Safety Reporting Specialist Month Year Collaborated with interdepartmental teams and external entities to ensure timely regulatory submissions achieving compliance with global clinical trial safety reporting requirements. Conducted root cause analyses for delayed submissions, enhancing reporting processes and adherence to global regulatory agency requirements. Analyzed and implemented safety reporting policies based on FDA EU ICH and GCP guidelines providing technical guidance and ensuring accuracy in expedited and periodic safety report submissions.INC Research, Raleigh, NCSenior Safety Specialist Evaluated and processed safety reports, ensuring precise entry into the Argus Safety database for lifecycle cases utilizing MedDRA and WHO drug dictionaries for accurate coding. Performed thorough follow up on adverse events securing comprehensive and precise case data and addressed medical information requests concerning adverse events and product complaints. Managed a diverse portfolio of pharmacovigilance products maintaining a strong commitment to delivering on schedule outputs in alignment with regulatory requirements. Quintiles, Morrisville, NCSenior Operations Specialist Ensured compliance with safety reporting requirements and processed safety reports within established timelines enhancing data integrity and adhering to regulatory standards. Analyzed relevant literature and managed lifecycle safety data including narrative writing and term coding within the GSD ensuring thorough and accurate drug safety activities. Conducted quality reviews of safety reports, developed operational documentation, and managed SOP change control contributing to the maintenance of high-quality standards and procedural consistency. Facilitated training programs for junior staff focusing on skill development and process improvement while overseeing the case workflow to optimize team performance and the regulatory submission processes.EDUCATION AND CERTIFICATIONSNorth Carolina Central University Durham, NC Bachelor of Science in NursingUniversity of California San Diego, CA Regulatory Affairs Essentials CertificateSKILLSClinical trials Safety Submissions Vendor oversight Narrative writing Reconciliation Drug Safety Pharmacovigilance Regulation knowledge Risk management Medical writing Data Analysis Time management Communication Unblinded safety information Term coding Leadership Project Management Attention to details Problem solving Program management Process Improvement Operations management Collaboration ICSR Management Quality Control SOPs Training Good Clinical Practice Subject Matter Expert |
