Cara Robichaud Email & Phone Number

Bluffton, In, Us

Bluffton, Indiana, United States

• Performs safety case processing tasks including, but not limited to:o Intake and triage tasks as applicable for assigned projectso Reviewing incoming safety information for completeness and accuracyo Tracking and data entryo Writing clinical narrativeso Generating querieso Follow up with sites for missing and/or unclear informationo QC of cases and provide feedback as appropriateo Generating regulatory reportso Reconciliationo Generating metrics• Serve as Safety Management lead on moderate to large sized studies/programs that are moderate to complex in scope of work with minimal guidance. Responsibilities include, but are not limited to:o All aspects of Safety Management start-up process including writing Safety Management Plan, developing SAE form, etc.o Attendance at team and client meetingso Investigator's meeting attendance, if applicableo Presentationso Training and mentoring of staff on safety processeso Compliance with budget, including estimating monthly budget projections• Ensures compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager• May assist with bid defenses or other presentations• May mentor and/or train new Safety Management staff• Point of contact for queries from client or internal stake holders• Performs other related duties as assigned or requested by department management

Clifton Heights, Pa - Home Office

-Performs safety case processing tasks including, but not limited do:-Intake and triage tasks as applicable for assigned projects-Reviewing incoming safety information for completeness and accuracy-Tracking and data entry-Writing clinical narratives-Generating queries-Contacting sites for missing and/or unclear information-QC of cases and provide feedback as appropriate-Generating regulatory reports-Reconciliation-Generating metricsMay serve as Safety Management lead or back-up lead on small to moderate-sized studies that are simple to moderate in complexity and scope of work with guidance from senior staff. Responsibilities include, but are not limited to:-All aspects of Safety Management start-up process including writing Safety Management Plan, developing SAE form, etc.-Attendance at team and client meetings-Mentoring of staff on safety processes-In collaboration with manager, supports compliance with client budget and proactively escalates potential scope changes or noncompliance with cost or time allocation to department Manager.-May assist with bid defenses or other presentations.-May mentor and/or train new Safety Management staff.-Communication with the client or internal stakeholders as applicable.-Performs other related duties as assigned or requested department Management.

King Of Prussia, Pa - Home Based

• Attend project and departmental meetings, as required• When appropriate, in conjunction with the sponsors and senior team members, review pharmacovigilance aspects of a given study• Discuss, when appropriate with sponsor or Covance medical team, any issues arising from adverse events reported to pharmacovigilance• Proactively gain awareness of regulations and timelines associated with reporting SAEs to Regulatory Authorities, Ethics Committees, Investigators and EudraVigilance• Maintain awareness of current development pharmacovigilance legislation• Pursue continuous educational training by reading and assimilating subject relevant Regulations, Directives, Guidelines, and any applicable national legislation• Perform safety event review, tracking and reporting to sponsors or agencies for assigned projects• Ensure that all internal systems are routinely updated as appropriate• Set up and lead low volume or partial service projects with close supervision from line manager or more senior PV team members• Assist with the submission of expedited and periodic reports and associated tracking• Perform other duties as required by the Department• Oversee, assign and QC of PVO case processing• Assist with the drafting of Working Instructions• Create and maintain accurate Outlook email templates for study distribution lists

King Of Prussia, Pennsylvania (Home - Based)

As a member of the Pharmacovigilance (PV) Team, I completed the daily review of SAE reports, generation of queries for missing or inconsistent data, as well as the preparation of SAE narratives. Provided support by advising colleagues on areas for improvement within departmental and/or project specific processes and facilitated the necessary changes. Set up and led partial and full-service projects while consistently providing supplemental support to other team members and projects. • Attend project and departmental meetings, as required• When appropriate, in conjunction with the sponsors and senior team members, review pharmacovigilance aspects of a given study• Discuss, when appropriate with sponsor or Chiltern medical team, any issues arising from adverse events reported to pharmacovigilance• Proactively gain awareness of regulations and timelines associated with reporting SAEs to Regulatory Authorities, Ethics Committees, Investigators and EudraVigilance• Maintain awareness of current development pharmacovigilance legislation• Pursue continuous educational training by reading and assimilating subject relevant Regulations, Directives, Guidelines, and any applicable national legislation• Perform safety event review, tracking and reporting to sponsors or agencies for assigned projects• Perform booking a case, case processing, closing, and the QC entailed in fully closing a study• Ensure that all internal systems are routinely updated as appropriate• Set up and lead low volume or partial service projects with close supervision from line manager or more senior PV team members• Assist with the submission of expedited and periodic reports and associated tracking• Perform other duties as required by the Department

King Of Prussia, Pennsylvania (Home Based)

Member of the Pharmacovigilance (PV) Team; performs daily quality control (QC) of Daily Safety Reports (DSRs), reviews subject narratives for Protected Health Information (PHI) and alerts proper personnel if any is discovered, monitors/QCs the daily filing of email correspondence between PV Officers and medical monitor (MM), PHI review emails, PV Officer Assignments, and retrieval of MCN#s from the DSRs. Assists or leads reconciliation of Serious Adverse Events (SAE) cases within AERS. Completes daily Data Entry (DE), including booking new cases, updating follow-ups (FU) and general QC within Argus and AERS. Responsible for generating queries or contacting sites regarding past due queries generated by PV Officers. In charge of keeping live case status trackers up to date. Lends support to the PV Team by any means necessary. • Liaises with external contractors and clients• Applies Good Clinical Practices documentation as well as strictly adhering to SOP• Completes non-project and project related tasks (e.g. administrative tasks)• With minimal to no guidance from manager, ensures all internal systems are accurate and up to date• Supports PV Officers with SAE reconciliation and collection of regulatory information• Supports with the development and delivery of reports as required• Supports with training and mentoring• Attends study meetings• Review and updates subject files and SAE narratives• Conducts regular case, subject file, and filing QC• Reconciliation on SAE cases within AERS• Generates DSMB listings, reconciliations, and case/query listings• Supports PV Officers with generating and sending queries to sites• Data Entry within AERS & Argus – Booking-in, regular updating, QC• Maintenance of Live Case Status trackers

King Of Prussia, Pennsylvania (Home Based)

Key Areas of Responsibility • Same as the above job description for Chiltern

• Train new employees on detail work, cleaning instructions as well as health and safety hazards• Provide custom cleanings for businesses and residential areas• Ensure customer satisfaction by being punctual and maintaining a consistent quality of work

• Perform preservation procedures to delay decomposition• Delegated embalming tasks based on the state of remains as required (ie. If an autopsy was performed or if remains have significant decomposition)• Support Professor and staff as needed• Ensure that all required paperwork is received, filled out and delivered to pertinent parties (ie Auptosy results, Death Certificate, etc)• Accurate reporting of details during embalming • Maintenance of autoclave, centrifugal pump, and operating table• Ensure sanitation, preservation, and presentation of the remains

• Prepared beverages and pastries for customers• Maintained a cleanly environment

Bachelor'S Degree, Health Studies, Disaster And Emergency Management, 3.74 Gpa

Graduated

Bachelor Of Science, Pathobiology

Activities and Societies: American Chemical Society, American Medical Student Association

Associates In Applied Science, Funeral Services, 3.5 Gpa

Activities and Societies: Sigma Phi SigmaPassed National Boards, May 2010