EMMANUEL M. JOSEPH, BSN, RN

** ****** **** • Spring Valley, 10977

Home 845-***-****, Mobile 845-***-****, n6nxnk@r.postjobfree.com

Highly motivated second-degree Bachelor prepared registered nurse with relevant clinical competence of nursing practices and strong current knowledge of the nursing process and its application. Possess over 12 years of experience in clinical trial and Stability study project management in the pharmaceutical industry. Have expertise in global R&D, clinical trial and Stability research Programs for new drug discovery from pre-development through registration and marketing. Possess extensive knowledge of regulatory requirements and ICH guidelines.

Seeking a Clinical Safety Specialist or Pharmacovigilance position where my extensive Pharmaceutical and medical expertise can be utilized to positively impact your organization.

ATTRIBUTES:

• MULTI-TASKING INDIVIDUAL ● COMPLIENCE DRIVEN

• DETAILED ORIENTED ● POSESS GREAT ORGANIZARIONAL SKILLS

• ORGANIZED PLANNER / DECISION MAKER ● EFFECTIVE COMMUNICATOR (oral and written)

• FAST LEARNER ● GREAT TECHNICAL ABILITIES

PROFESSIONAL EXPERIENCE

GENZYME BIOSURGERY-RIDGEFIELD, NJ 4/2010 TO PRESENT

Senior Stability Specialist Quality Assurance

• Manage stability studies to support clinical trials for new drugs and new medical devices discovery and development.

• Conduct post marketed stability studies to maintain and ensure quality and safety of marketed drug products and medical devices

• Develop protocols for clinical studies and clinical trials in accordance with institution policies and regulatory agencies guidelines and regulations to ensure implementation and fulfillment of annual goals and objectives for well defined pharmaceutical drug products and medical device projects.

• Compile, evaluate, analyze and manage clinical research data and write final technical reports for filing with regulatory agencies.

• Conduct post marketed stability studies to maintain and ensure quality and safety of marketed drug products and medical devices

• Compiled, reviewed and trended data to support drug substance, drug product, medical devices and intermediate revalidation period, proposed shelf-life and period-of-use dating.

• Generate stability reports to support regulatory filings, to extend revalidation periods, clinical POU (period of use) extensions for clinical research drug products and medical devices

• Analyze stability and analytical data to establish API and drug product specifications and proper storage conditions and packaging configurations.

• Determined Stability Impact assessment for clinical research products.

• Generate PDIR and CAPA, written and revised SOPs.

Clinical Experience: Rockland Psychiatric Center- Orangeburg, NY 12/2010 TO PRESENT

Nurse II Psychiatry

• Provide day to day care for patients with physical and mental illnesses.

• Responsible for administering and evaluating patient’s response to pharmacological therapy.

• Engaged client’s in mentally stimulating activities to enhance cognitive abilities and coping skills.

• Perform complete physical assessment of clients upon admission to the unit and on a monthly basis.

• Assists in development, implementation, and evaluation of standards of care and professional. practice in collaboration with members of the health care team and in accordance with. institutional policies and regulatory agency requirements.

• Teach patients about mental illness and the importance of remaining compliant with therapeutic regimens.

• Develop mentally stimulating programs to provide patients with a sense of self worth.

• Engage in therapeutic communication with patients to promote self reflection.

• Prepare clients for scheduled medical procedures.

• Perform medication reconciliation.

• Perform daily review of the MAR to ensure medication accuracy with physician’s order forms.

• Perform client’s chart auditing and purging.

• Collect client’s specimens for laboratory procedures.

• Generate daily and monthly progress notes to address the patients conditions and progress

• Coordinate patient care activities, based on established priorities, including teaching, counseling, and discharge planning, and directs/delegates appropriately to members of the health care team.

• Demonstrate responsibility and accountability for nursing practice and the delivery of safe, competent patient care.

• Maintain clinical competence and is responsible for own professional growth and development along the continuum from advanced beginner to expert.

• Participate in the design, measurement, and assessment of care related structures, processes, and outcomes to improve the quality of patient care.

• Participate in maintaining a safe, therapeutic, and consumer oriented environment.

• Promote positive consumer interactions and upholds the Patient Bill of Rights.

• Perform medication reconciliation, chart auditing.

• Participate in identification, response to, and investigation of potential and actual risk management issues.

• Evaluate client’s responses and outcomes to therapeutic regimens and plan of care.

Jan 2010-April 2010 Westchester Medical Center Valhalla, N.Y.

Clinical Preceptorship (Post Anesthesia Care Unit (PACU)) (140 hrs)

• Cared for critically ill and sedated clients under the direction and supervision of a preceptor.

• Monitored for change in vital signs and signs of ICP, performed complete neurological assessment.

• Assess for patency of Central Venous Access Devices (PICC, MLC and Percutaneous central catheters). Primed, flushed, changed IV lines and administered IV piggyback medications and fluids.

• Administered oral, IM, and subcutaneous medications.

• Admitted and transferred patients to and from the MICU under the direction of preceptor.

• Received patient load as a senior leadership student; generated patient care plans, assessments, interventions, outcomes, teaching sessions, and computerized documentation.

• Provided pre and post-op nursing care for surgical patients admitted after surgeries.

• Collaborated effectively with interdisciplinary teams of medical and health care professionals comprised of a physician, nurse manager, dietician, social worker, case manager, and physical therapist.

PFIZER/WYETH PHARMACEUTICAL – Pearl River, NY 1999 TO 4/2010

Research Scientist I

Managed all stability activities related to assigned clinical research projects required to ensure successful development, filing, and marketing of pharmaceutical drug products. Supported formulator studies, monitored and managed clinical stability studies, and NDA (New Drug Application) to support commercial filing of pharmaceutical drug products. Determined Stability Impact Assessment for Laboratory Investigation Reports and Process Discrepancy Reports. Participated in departmental computer system development and validation activities, and training of team members.

EDUCATION AND CREDENTIALS:

Bachelor of Science in Nursing (May, 2010)

DOMINICAN COLLEGE – Orangeburg, New York

Licenses: NYS Registered Nurse (license # 635607)

NJS Registered Nurse (license #26NR15876700)

Bachelor of Science Biochemistry (1999)

STATE UNIVERSITY at Albany – Albany, New York

Associate in Math and Science (1996)

ROCKLAND COMMUNITY– Suffern, New York

Skills

Certified CPR

Extensive knowledge of Microsoft office, LIMS, Labware, Novatek and various other Laboratory management software

PROFESSIONAL AFFILIATIONS:

American Nurses Association

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