Scott Blanchette Email & Phone Number

Salem, Ma, Us

Waltham, Ma, Us

•Monitor daily post-market surveillance detection reports for reportable adverse events across various data registries including: NMOSD, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, IBD•Creation of ICSR process workflow SOPs for process improvement as well as ICSR stylistic guidelines for reporting uniformity for clients/vendors across all registries•Responsible for all safety reporting deliverables for assigned data registries, with emphasis on completeness, accuracy, and on time delivery to clients•Oversee management and mentoring of ICSR staff for triaging of new events, collection and review of source documentation, case processing, and submission to clients in accordance with agreed upon expedited event timelines•Work in multiple EDC systems in conjunction with various clinical departments to ensure complete and accurate entry of drug safety data.•Work with the Drug Safety staff to manage adjudicator caseloads and triage assignments for assigned registries, based on scientific priorities•Serve as PV lead in all cross functional registry meetings for internal project teams•Manage staff of PV associates and assign tasks per client deliverables across multiple assigned registries•Worked with cross functional clinical teams for inspection readiness as well as drafting inspection readiness plans for all applicable Pharmacovigilance•Supervision of CAPA processing including CAPA authoring, root cause analysis andimplementation of corrective and preventative actions

•Assess and processed events (reported and/or discovered per publication review) in accordance with all applicable regulations•Compose narratives for case reports as well as preparation and submission of case reports for medical review •Preparation of regulatory reports including but not limited to DSURs, PSURs, PBRERs and PADERs •Assist in SAE reconciliation between Safety and medical information databases and served as a departmental Pharmacovigilance subject matter expert.•Work across multiple product lines for various clients in both clinical and post-market settings•Serve as post-market contact liaison between medical reviewers and customer complaint contacts to investigate reported events and obtain additional information for regulatory reporting purposes

Marlborough, Massachusetts, Us

• Project lead for various drug and medical device trials• Lead PV representative/participant for all local safety related audits• Lead PV representative for local bid defenses in cooperation with Business Development group• Assist with creation and distribution of annual safety reports (ASRs) and Development Safety Update Reports (DSURs)• Create case narratives for medical review• Query sites for SAE report completion • Processed and review adverse event information in the product safety database. • Maintain awareness of medical terminology and MedDRA coding dictionary conventions. • Ensure ongoing safety review at case management level • Maintain up-to-date knowledge of PV regulatory reporting requirements for submission of reportable events• Attain and maintain proficiency in the use of the product safety database. • Work with clients to devise, produce and maintain working procedures to ensure regulatory compliance. • Maintain awareness of changes to and implementation of new local regulations.

Marlborough, Ma, Us

• Worked on Cardiology, Endoscopy and Urology studies • Acted as clinical team contact for safety related issues• Wrote event narrative submissions for Safety Surveillance MD level approval• Processed product complaints and product malfunction narratives for Safety Surveillance and Corporate Complaints departments• Generated site queries on study CRF issues, data discrepancies and adverse event clarifications• Participated in UAT for Safety study start-up in both EDC and multiple safety databases• Contacted study sites for event verification and source document collection• Performed reconciliation of data across EDC and safety database platforms• Ran and distributed safety data listing reports through safety database as well as in coordination with Biostatistics group• Conducted multiple cross departmental training sessions and served as departmental subject matter expert for various EDC versions • Assessed events based on seriousness criteria and causality• Coordinated event and source document information between sponsor and participating CROs• Assisted in various Corrective and Preventative Action (CAPA) programs for submission to FDA

Marlborough, Ma, Us

•Initialized event information across multiple medical device trials into safety database•Maintained and distributed event dossiers to Clinical Events Committee for adjudication•Collected and distributed safety event source documents•Created and organized safety event dossiers•Maintained and distributed various study safety event trackers

Us

•Received and performed data entry of initial event information into Oracle AERS database•Contacted study sites to collect complete event source document for safety events•Reviewed adverse event data for completeness and accuracy•Assisted Regulatory Affairs in FDA submissions•Tracked adverse event statuses across various clinical trials•Generated and tracked letters for Drug Safety group, including expedited safety reports•Maintained files for patient AE/SAE information•Worked with Drug Safety staff to help maintain Oracle AERS system performance•Supported Director of Drug Safety and Surveillance in day to day activities

Durham, North Carolina, Us

-Worked on clinical trial audits to ensure quality of data, resulting in successful database locks-Created and developed SOPs for company-wide maintenance of internal training records-Managed training help desk to provide employees with answers to training-related inquiries-Trained employees on use of training software for Medical Terminology and SAS Programming

Master Of Science, Regulatory Affairs

Education record