Provides oversight and delivers result driven training to vendors in the scope of clinical case processing, including initial triaging, seriousness assessment, labeling, and causality, in order to comply with global regulatory agencies.Manages training materials for vendor responsibilities including clinical case processing of SAEs, SUSARs, quality checks and train the trainers.Performs quality review of vendor’s activities.Oversees vendor analysts to ensure quality and consistency in case processing. Leads clinical case processing calibration meetings with vendor.Conducts late case investigations/ CAPAs.Functions as therapeutic area lead for investigational compounds, including attending study level meetings, collaborating with different roles and departments, and serving as compound contact.Performs upfront triage and selects cases for training vendor MSAs.Mentors and orients new team members.Participates as subject matter expert transitioning to new EDC database.Performs SUSAR manager review.

Collected, assessed and processed both clinical and post-marketing adverse event information in compliant and timely manner, including performing triage of seriousness assessment, labeling, and causality.Met company standards for quality, compliance and productivity.Met case quality and case processing metrics, including processing SUSARs.Consistently grew in knowledge and expertise to and closely collaborates with other MSAs and other therapeutic areas in case processing to improve case processing quality.Followed-up with clinical sites via queries to obtain additional information or clarification regarding adverse events until resolution.Participated in Adverse Event Quality Program and evaluated Individual Case Safety Reports for accuracy and quality.Functioned as Therapeutic Area Lead for compounds in General Medicine Pillar.

Reviewed safety-related data from clinical trials for content, quality, and adherence to ICH/ GCP guidelines and protocols.Analyzed and allocated Serious Adverse Event (SAE) and Adverse Event (AE) information in order to assure accuracy and completeness of electronic files and fulfill timely reporting in accordance with regulatory requirements.Participated in safety surveillance activities for clinical trials including medical review of Clinical Report Forms, labs, medication classifications, and coding terms. Collaborated with SMAs, CRAs, Data Management, PV, and Study Physicians to assure quality data and query resolution.Created narratives for SAEs and other identified AEs of special interest for regulatory submission.

Monitored and provided nursing care for patients in critical or life-threatening condition.Assessed critical patient conditions and administered life-saving medications.Observed behavior and symptoms and reported changes to intensivists and on-call physicians.