Bachelor of Science in Nursing @
Central Missouri University
Broad based professional RN, BSN in Clinical Research, Clinical, & Post-Marketing Drug Safety with 13 years’ experience in global pharmaceuticals (US, EU, & ROW) and healthcare industry. Consistently increasing responsibilities in employee and project management. Strong expertise in globally regulated drug and clinical trials environments with regulatory agencies. Strong leadership abilities, able to act as a collaborative
Broad based professional RN, BSN in Clinical Research, Clinical, & Post-Marketing Drug Safety with 13 years’ experience in global pharmaceuticals (US, EU, & ROW) and healthcare industry. Consistently increasing responsibilities in employee and project management. Strong expertise in globally regulated drug and clinical trials environments with regulatory agencies. Strong leadership abilities, able to act as a collaborative facilitator and leader, and known for being able to motivate cross-functional teams, team members, and vendors to achieve results. Strong ability to work independently and make effective decisions to meet strategic objectives and goals.
• Clinical & Post-Marketing AE Reporting
• FDA & EMEA Audit Experience
• AE Triage, AE Report & Narrative Review/Auditing
• Project Management / Training
• Medical Records Review/QC
• Clinical Trial Planning & Implementation
• Risk Management & REMS Experience
• CRO/Safety Vendor Management/Auditing
• SOP & Work Instruction Creation
• MS Word, Excel & Power-Point Experience
• Regulatory Experience with GMP, GCP & ICH
• Experienced with MedDRA coding
• CAPA Plan Creation and Implementation
• Familiar with AERS, Aris-g, Oracle, & InForm
Manager of Pharmacovigilance Quality Systems, Training, and Standards @ Oversee global PVG quality and audit processes for clinical trial and post-marketing AE, PC & MDR reporting to ensure quality and timely delivery of safety reports. Manage and maintain metrics on adherence to regulatory requirements for AE reporting. Develop and oversee Quality Management Plans (QMPs) for PVG outsourced functions including third party vendors, SPSs and Call Centers. Conduct quality control activities including audits with Global Regulatory and Compliance in order to determine vendor compliance with SOPs, GCP and applicable regulations. Provide feedback on findings with critical attention to addressing issues with solutions oriented proposals. Assist with PVG outsourcing strategy to provide PVG operations oversight of a vendor environment and infrastructure. Review of all PSURs, PADERs, DSURs, IBs, SMPs and Protocols.
• Responsible for review and clarification of all IB, PSUR, PADER and DSUR reports prior to submission.
• Created PVG standardized procedures, documents and metrics to measure productivity of PVG operations.
• Serve as key point of contact for internal PVG discussions and third party vendor drug safety questions.
• Provide all global employee, third party vendor, and contract employees PVG reporting training.
• Provide interpretation of data results and provide feedback to vendors to improve PVG quality standards.
• Responsible for SOP review, revision and creation to meet global quality PVG standards. From May 2011 to Present (4 years 8 months) Sr. Drug Safety Associate II Drug Safety and Risk Management @ A global biotechnology company of 4500 employees. Biogen Idec specializes in drugs for neurological disorders, autoimmune disorders, and cancer.
Managed post-marketing AE (adverse events) and medical review for 260 Patient Services Associates, (avg.150 reports daily), to ensure AE reporting compliance. Conducted AE reporting training and mentoring for Patient Service Associates. Triaged reporting of serious adverse events to FDA, and Canada Health. Familiar with Risk Map/REMs (Risk Evaluation and Mitigation Strategies). Responsible for late case root cause analysis, metrics and corrective and preventative action (CAPA) plans for issues of non-compliance/documentation. Assisted with management of CRO adverse event reporting and AE call center. Assist in managing, training, and mentoring new drug safety employees.
• Manage TSN (Therapeutic Support Nursing) with 27 reports, and ANE (Avonex Nursing Educators) Partner with 8 reports; responsible for AE reporting, providing feedback, and disciplinary actions.
• Created Patient Services AE Reporting (Excel) Metric Reports and provided analysis of safety data increasing reporting percentages from 50% to 85%.
• Attend/lead task force meetings that lead to new AE reporting methods/procedures resulting in saving two FTEs,
(approx. $240,000.oo annually). From May 2006 to June 2011 (5 years 2 months) Drug Safety Scientist @ A pharmaceutical company of 2500 employees that engages in the research, development of drugs for the treatment of cardiovascular diseases, disorders of the central nervous system and of the gastrointestinal tract, and urological disorders.
Coordinated, review, reporting, and narrative writing for adverse events for multiple global protocols, phase II to phase IIIb in clinical drug studies. Review safety section of new protocols & amendments, for Drug Safety. Review safety data reports, and worked with IRBs. Assisted with creation of new global working processes and Safety SOPs.
• Created SOPs and work instructions for CRO AE processing in US and Europe.
• Created new SAE form and Work Instruction Sheet enabling AE reports to be entered 10% faster.
• Lead review for implementation of a new safety database (Aris-g). From March 2004 to April 2006 (2 years 2 months) Clinical Nurse Diabetic Educator @ Educated newly diagnosed diabetic children and their parents. Responsible for patient triage, making insulin adjustments, and advising patients. Provided diabetes presentations and diabetic education classes. From January 2004 to May 2004 (5 months) Pharmacovigilance and Epidemiology Officer @ Employing 23,000 workers in 60 countries that have helped develop all of the top 30 best-selling drugs. A fully integrated bio and pharmaceutical services provider offering clinical, commercial, consulting and capital solutions.
Oversaw phase I to phase IV clinical trials safety data, and associated PSUR data review. Responsible for overseeing review of patient medical records, coding events, safety signal detection reports, and providing medical follow-up to company physicians. Oversaw reconciliation of data in safety databases and the clinical study databases. Responsible for Pharmacovigilance narrative writing and review. Provided adverse event training to clinical research associates and investigator sites.
• Supervised Endocrinology clinical trials safety group and responsible for mentoring and growth within the organization.
• Interacted with FDA officials during four routine audits with no findings.
• Responsible for triage and determination of report ability of adverse events.
• Assisted in the design of new protocols, and CRF AE pages for 10 studies.
• Attended interdepartmental meetings to develop relationships with cross functional team members. From October 2002 to January 2004 (1 year 4 months) Safety Associate @ Collected and reconciled AE data between the safety and the clinical databases. Responsible for creating queries to sites and clarifying safety information. Provided adverse event training to clinical research associates and investigator sites.
• Supervised inspection of medical devices and responsible or Medical Device Reporting (MDR) and made
improvements to the PTC (product technical complaint) forms.
that resulted in quicker data entry times.
• Created new AE reconciliation process that decreased reconciliation time by 10% - 15%.
• Oversaw reconciliation of data in safety and clinical databases which lead to early filing of IND.
• Supervised clinical research associates collection of AE data. From March 2000 to October 2002 (2 years 8 months) Clinical Research Associate @ NOTE: Quintiles purchased Hoechst Marion Roussel Pharmaceutical Clinical Dept., Kansas City, MO in 1998.
Organized study start-up activities, site selection, pre-study, initiation, interim monitoring, and close-out visits. Responsible for monitoring multiple study sites to assure compliance with protocols, resolving queries, reporting all adverse events, drug accountability, CRF review. Created CRF and IC pages. Supervised collection of CRF pages and cleaning of data by new monitors and interns. Mentored new CRAs in the areas of DCF resolution, listing reviews, and monitoring. Worked with specific vendors to obtain and distribution study materials to sites.
• Assisted in writing specific Protocol sections, and creation of new CRF page formats resulting in better data
collection from sites.
• Assisted in creation of a “Computer Dose Titration Tracking Schedule” for Investigator sites to compare study drug
data verse comparator drug, used in 4 clinical studies the program enabled real time review of data and decreased
data collection time by 25%.
• Responsible for study site audits and evaluations resulting in one site shut down. From September 1999 to March 2000 (7 months) Weekend Unit RN Supervisor, Neuro / Orthopedics / Floating Staff Nurse RN @ Assigned weekend work schedules, managed conflicts and/or problems arising on the floor, met with patients and provided for family’s needs. Mentored new nurses (RNs, LPNs, & CRNAs) assigned to the floor. Responsible for pre and post-operative treatment and care of stage I-IV brain tumors. Coordinated and schedule pre and post-operative Gamma Knife surgery patients. Responsible for pre and post-operative patients with total knee & hip and replacements. Mentored new graduate nurses and helped them develop good nursing skills.
• Oversaw staff RNs, LPNs and Nursing Assistants assigned to the unit.
• Acted as the hospital 6th floor Baxter intravenous pump instructor. From October 1997 to September 1999 (2 years) RN Nursing Supervisor @ Managed the care of 47 residents on the facilities 3rd floor. Provided assessment and treatment to residents with
minor to complex health problems.
• Scheduled nursing staff and held monthly review meetings.
• Supervised 2 LPN’s, 4 nursing assistants and 1 medication technician. From April 1996 to October 1997 (1 year 7 months)
BSN, Nursing @ Graceland University From 1993 to 1995 Central Missouri University Sean BSN is skilled in: Therapeutic Areas, Hypertension, Oncology, Neurology, Endocrinology, Pharmacovigilance, Diabetes, Pharmaceutical Industry, GCP, CRO, Clinical Trials, Clinical Research, Protocol, FDA
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