RENEE HOLLAND

South Shore, Massachusetts (C) 508-***-**** E-mail: ad4wz7@r.postjobfree.com

PROFESSIONAL EXPERIENCE

Careforth, Quincy MA (4 month contract 2023)

Administrative Support

- Sorted, categorized and processed employee files in preparation for off-site archiving

EMD Serono, Rockland, MA (5 month contract 2021)

Senior Drug Safety Associate

- Sought comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event (AE) information

IQVIA, remote (6 month contract 2021)

Senior Drug Safety Specialist

- Received, triaged, reviewed and processed AE data from various sources, performing data entry for tracking and safety database, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, and coordinating translations

IRONWOOD PHARMACEUTICALS, Boston, MA (2014-2020)

Manager, Global Patient Safety (GPS) Operations (2018 – 2020)

Senior Drug Safety Associate (2014 - 2018)

- Trained, mentored and oversaw vendor handling of pharmacovigilance safety information including collection, registration, and transmission to GPS, as applicable, in a timely manner

- Ensured accurate transfer of information from initial and follow-up source documents, or E2B inputs for AE reports, to appropriate fields within Argus; coding AEs, concomitant medications and medical history using MedDRA, and managing case reports within the Argus workflow to meet local and global regulatory timelines

- Completed AE and database reconciliation with internal departments and external partners monthly; Monitored and maintained Safety-related mailboxes daily

- Prepared timely submission of reports to regulatory agencies in accordance with applicable regulations - including United States DSUR and global PBRER reports; Participated in audit preparedness and supported Partner and/or Regulatory audits

- Reviewed aggregate safety data output from the safety database for activities related to compliance, metrics, monitoring KPIs or Partner related activity

- Determined root cause analysis for deviation and Corrective and Preventive Actions (CAPA) activities in relation to late report submissions and relating to case management processes

- Served as a project team member for Drug Safety and Pharmacovigilance (DSPV), with cross-functional teams from Documentation Management and Informational Technology (IT), to coordinate the transfer of all DSPV files and emails to a company-wide shared drive

BIOGEN IDEC, Cambridge, MA (1993-2011)

Senior Data Specialist, Drug Safety and Pharmacovigilance (2006-2011)

Data Specialist, Drug Safety and Pharmacovigilance (2000-2006)

Data Editor (1997-2000)

Data Entry Operator (1993-1997)

- Processed pre and post marketing AE case reports from initial receipt to medical follow-up; Performed quality review and case closure activities

- Ensured compliance with corporate and departmental Standard Operating Procedures (SOPs) via Business Objects queries and Data Conventions; Established compliance in expedited reporting

- Initiated, implemented and maintained the company Product Expected Lists which also served as the template for the European office. Authored company-wide Work Instruction (WI)

- Reviewed and processed serious and non-serious product complaints of AEs, including those associated with a medical device, for the FDA, Health Canada and ROW; Initiated and completed the monthly reports for extensive review

- Created and/or generated data queries based on validation checks or errors identified during the data entry process

- Performed QC audits to ensure accuracy, completeness and proper usage of clinical systems and data

- Led a Global Quality Taskforce

SOFTWARE / TOOLS

Microsoft Office (Word, Excel, PowerPoint, Sharepoint, Outlook, Access), Lotus Notes, Paradox, Admins, ClinTrace, Oracle AERS, Oracle Argus, PDCS, MedDra, WHODrug, Business Objects, Siebel, and PRIMO

EDUCATION

B.A. Business Management

Curry College, Milton, MA

A.A. Merchandising

Newbury College, Boston, MA

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