Registered Nurse Manager
Resume:
Susan Giarrusso
*** ********** **. ******, **. **064
(P) 603-***-**** Email: ***********@*******.***
Summary of Experience:
Registered Nurse with experience as Case Manager in Home Care and drug safety, as well as a variety of staff positions. Major strengths in verbal and written communication skills and time management. Proven ability to work independently or as member of top performing team.
Employment History:
Sr. Safety Specialist for Pharmacovigilence and Risk Management:
Sunovion Pharmaceuticals, Marlborough, MA. Nov-2011-June 2012
- Drug safety activities provided for phase I - III clinical trials and post-marketing surveillance.
- Therapeutic experience with CNS, Respiratory, Epilepsy, Schiophrenia and Bipolar clinical trials
- Experience with drug safety and clinical trial databases (AERS, InForm, JIRA)
-Provides regulatory assessment of individual case safety reports to Regulatory Authorities world-wide, including determination of timeframes for compliant regulatory submission of all serious adverse experience reports received by Sunovion.
-Generates IND Safety reports/CIOMS forms and submitting to appropriate primary regulatory authorities associated with expedited reporting.
- Tracks safety and regulatory submission within the safety database.
- Created QSR for products and recently worked on Lunesta PSUR for FDA submission using ICH guidelines.
- Updated AERS manual for post marketing and clinical case outsourcing
- Database lock: SAE reconciliation, Adjudication (CLAERITY, recently)
- Signal detection, RMPs, Aggregate reports, literature searches and responsible for manning the AE mailbox and RightFax on a weekly rotation.
- MedDRA and WHODrug through AERS, was point person for reviewing and conversing with physicians on manual coded terms to decide if they would remain in new version of MedDRA 15.0, in May 2012.
Drug Safety Associate: Sunovion Pharmaceuticals, Marlboro, MA.
November 2010 - Nov-2011
- Post marketing reporting of serious/ adverse experiences (SAE/AE),
- implementing appropriate SAE tracking systems including entry and reporting
- writing adverse event narratives, reviewing protocols, Case Report Forms and processing of clinical case reports.
-frequent contact with study sites. MD’s and consumers to obtain additional information required for preparing and processing reports.
- Studies included: Respiratory, CNS and Schizophrenia.
- Experience with AERS Oracle, InForm, Excel, Power Point, Microsoft Office, MedDRA and WHODrug through AERS.
Susan Giarrusso
Drug Safety Associate: PAREXEL International, Waltham, MA,
February 2009 – Nov 2010
- Reported serious adverse experiences (SAE), implemented appropriate SAE Excel spreadsheet tracking systems
- Case data entry, writing narratives, reviewing protocols and Case Report Forms.
- Contact with study site coordinators and investigators to obtain information required for preparing and processing reports.
- Collaborate with project management as well as sponsors to ensure timeliness of adverse experience reporting.
- Participated in internal and external audits on various studies including CEC (critical endpoint)
- Study start up including creating SMP, DEGs and review ICFs
- Experience with: - MedDRA, some WHODrug, Centocor PDS, Medidata (RAVE), InForm, NWAES, CIMS, PMED, VPS, Excel, Power Point, Microsoft Office, Argus and some Clintrace.
RN Care Manager: Enhanced Care Initiatives, Woburn, MA. March 2007-Dec. 2008
- Admit, discharge and manage all home care for Tufts patients involved in the Easy Care Wellness Program.
- Scheduled and supervised LPN's with follow up visits and calls.
- Responsible for 100 + patients in a large geographical area.
- Create plans of care with MDs as well as Case Managers to maintain level of care to decrease frequent hospitalizations.
- Maintain and send daily reports of all follow up appointments and care calls to physicians and case managers, perform chart reviews, and quality assurance with Case Managers.
- Maintained QI reports for the NY office re: hospitalizations for the Easy Care and Quality of Life (cancer) programs.
RN Clinical Liaison: Healthbridge Management, Lexington, MA.
2005-February-2007
- Screened potential rehab, Alzheimer’s and or long term care patients for placement in one of our 15 buildings throughout MA.
- Physician Liaison included: marketing physicians to obtain credentials in our buildings.
- Obtained a Wound Care MD, Ortho MD and Medical Director for Lexington facility from Mount Auburn Hospital.
- Supervised and trained incoming candidates in the liaison position.
- Increased census of LHC to full capacity of 158 patients within 6 months of start date.
RN Case Manager / Field Nurse: All Care VNA, Charlestown, MA.
2004-2005
- Management of patient care for Medicare, Medicaid and HMO patients which covered 5 territories.
- Acquired a caseload of approx 60 patients a week.
- Conversed with MD’s regarding patient care in the field, as well as monitored Coumadin levels, blood draws, catheters and wound care.
Susan Giarrusso
RN Nurse Specialist: Serono Labs, Rockland, MA.
2002-April 2003
- Managed over 2000 Multiple Sclerosis (MS) patients within 7 western states who were on Rebif.
- Responsible for maintaining an Excel spreadsheet of patients that had discontinued medication, reactions to and side effects from Rebif for the pharmaceutical representatives.
- Telephonic nursing assistance for patients’ regarding signs and symptoms of M.S., side effects of medication, set up training for self injections as well as reported adverse events to the drug safety department.
RN: Med/ Surgical/ Telemetry/ ER: UMass Memorial, Worcester, MA. and Children's Hospital, Boston 2001-2002
- Operated on medical surgical and cardiac floor and monitored telemetry patient's.
- Initiated IV access, catheters, tracheotomy care, blood draws, IV medications, C-lines, PICC lines and wound care.
- Transferred to ER after 8 months and resumed care of critical patients. as well as ER RN in Children's ER.
Emergency Medical Technician: Action Ambulance, Eascare and AMR, MA.
1991- 2002
- Provided basic life support to patients during emergency transports to hospitals.
- Obtained IV access, blood draws, administered IV hydration and medications and provided wound care.
- Held certifications in D-fib, CPR, Basic trauma life support and Pediatric trauma life support.
- EMS response with Stoneham, Waltham and Newton FD
- Transported critically ill children with Children’s Hospital Trauma Transport Team.
Education:
1996-1998 Lawrence Memorial Hospital School of Nursing Medford, MA
Registered Nurse
1992-1994 Mass Bay Community College Framingham, MA
Associates in Criminal Justice; Graduated with High Honors
1990 Somerville Hospital / Boston EMS Somerville, MA
Emergency Medical Technician
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