|Tammie A Kelsey
Extensive research career with recent focus on pharmacovigilance in the clinical trial and post marketing setting. Knowledge and skills in the following areas:
• Phase I, II, III, IV Studies • FDA Regulations/ICH Guidelines/GCP/HIPAA
• Pharmacovigilance Regulatory Requirements • Clinical Trial/Management
• Study Initiation/Closeout
• Clinical Study Reports/Tables/Listings
• Safety/Medical Monitoring Plans • Protocol/Study Procedures Manual
• Reports/Clinical Report Forms Monitoring
• Investigator Brochures
• FDA Audits • Quality Assurance Audits
SUMMARY OF QUALIFICATIONS
• Experienced in clinical trials, project leadership, clinical data management and pre/post marketing drug safety surveillance.
• Strong knowledge of pharmacovigilance in both the clinical trial and post marketing setting gained from 5 years of employment in the pharmaceutical industry and 10 years in the clinical research field.
• Certifications include ACRP Certified Clinical Research Coordinator (CCRC) with analytical and medical research experience.
• Significant training, continuing education and knowledge of Federal Regulations, Good Clinical Practices, ICH Guidelines and Standard Operating Procedures.
• Twenty five years of medical experience provides a strong medical foundation and a variety of transferable skills.
• Research experience includes expertise in producing, reviewing and collecting critical documents including Clinical Report Form’s (CRF/eCRF) and source documentation.
• Excellent qualifications in leadership and interpersonal communication skills. Comfortable speaking with a diverse audience.
• A team-oriented professional who works well under pressure, is goal oriented, with a commitment to patient safety and exacting research.
• Professional experience has provided exposure to: drug development process, clinical monitoring processes, collaborative opportunities, compliance, training, data collection, source documentation, validation, personnel management.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for problem solving and obtaining solutions.
• Successful interaction with sponsors, CRO’s, team members, and senior management members.
• Supervise and manage internal and external personnel to ensure timely initiation and completion of clinical studies and various clinical documents including those submitted to regulatory agencies.
Alexion Pharmaceuticals, Inc. 2009-Present
Pharmacovigilance Analyst/Specialist II
• Assesses events and effectively triages cases based on seriousness and expectedness.
• Responsible for providing quality documentation of safety data, particularly serious adverse events
(SAE’s), through direct contribution in a matrix environment.
• Ensures compliance with health authority regulations in all aspects of drug safety data processing
• Provides proactive safety surveillance across the lifecycle of Alexion products.
• Processes and assesses SAE’s from receipt to case closure in the safety database including query
generation and narrative writing.
• Conducts follow-up to complete needed adverse event (AE) information.
• Compilation of SAE Management Plan (SMP) covering SAE workflow between Clinical Research
Organization’s (CRO) and Alexion.
• Develops, reviews, and updates drug safety forms & templates for harmonization with relevant
clinical operation forms and templates (i.e. SAE data collection form and CRF).
• Collaborates with team members on the development and implementation of Pharmacovigilance
(PV) standard operating procedures (SOPs) and working processes (WPD).
• Drafts drug safety documents, including contributing to annual reports, and other periodic reports
• Oversees electronic and hard copy document management, retrieval, and archiving of PV
information including individual case summary reports to partners, CRO’s, and health authorities.
• Reviews and reconciles SAE data between clinical and safety databases.
• Interacts with clinical operations for assigned study protocols.
• Interacts regularly with medical information, regulatory affairs, commercial, and data
management groups on PV related issues.
• Remains informed of all appropriate current health authority regulations and guidance’s, including
those from ICH
• Relies on extensive experience and judgment to plan and accomplish goals.
• Acts independently to determine methods and new assignments
• Leads the continuous process improvement effort by developing, implementing, and documenting
all PV reporting conventions and training other team members and CRO’s with respect to Alexion
data collection conventions
• Drafts and performs first line review of Safety Monitoring Plan between CRO’s and Alexion.
• Contributes to the development of training courses for all study team members.
• Review Scope of Work (SOW) involving PV services from CRO’s.
Vion Pharmaceuticals, Inc.
Sr. Pharmacovigilance Coordinator 01/2007-10/2009
• Directly supported Vice President of Medical Affairs.
• Instrumental in creating Pharmacovigilance Department.
• Created and updated Pharmacovigilance standard operating procedures (SOP’s).
• Developed and reviewed all safety monitoring plans (SMP’s) and medical monitoring plans (MMP’s)
for all clinical trials.
• Assisted Clinical Affairs Department with development of clinical protocols, case report forms
(CRF’s) and informed consent forms (ICF’s).
• Received data from study sites and clinical research organizations (CRO’s) on all serious adverse
events (SAE’s) across all clinical trials conducted in both the United States and Internationally.
• Reviewed data from case report forms (CRF’s) and source documentation for medical content,
accuracy and completeness.
• Worked directly with CRO’s and clinical study sites to obtain all follow up information to complete
• Obtained medical monitor assessment and notifies investigators and regulatory authorities
• Tracked SAE data for trends requiring changes to the investigator’s brochure (IB).
• Assisted with annual IND safety report and updates to the investigator brochure (IB).
• Performed SAE reconciliation of clinical and safety database for all clinical studies and assisted study
sites on discrepancy resolution.
Clinical Project Leader
• Provided leadership in the development of study-related documents, including study protocols, informed
consent documents and investigator files.
• Established close working relationships with physicians, their research staff and outside consultants
through excellent communications on a regular basis.
• Provided review and approval of informed consent documents, monitoring reports and clinical study
• Participated in and conducted visits and meetings with investigational sites, physicians and consultants as
• Achieved study objectives by working with team members in setting project priorities, milestones and
resolving project conflicts.
• Tracked the collection of all study related and essential regulatory documents including site CV’s, IRB
approvals, patient enrollment forms, drug accountability forms, deviation/violation forms.
• Reviewed all study data and worked directly with study sites, monitors and CRO to reconcile all data
issues in order to facilitate study database lock.
• Reviewed all study tables and listings for accuracy and completeness for final study report.
• Co-author of Final Study Report for A Phase I Study of VNP40101M and Temozolomide In Patients with
Clinical Research Associate
• Involved in protocol design, planning, implementation and evaluation of Phase I-III
oncology clinical trials conducted in both the United States and Internationally.
• Reviewed data generated from clinical trials for completeness, accuracy and appropriateness.
• Resolved all questions immediately from investigators or CRO’s concerning issues arising in trials.
• Ensured timelines of trials while maintaining good clinical judgment and compliance with GCP,
FDA and ICH guidelines.
• Developed and implemented SOPs.
• Performed study site audits to ensured accuracy of clinical data and provide guidance to study staff.
• Reviewed regulatory documents according to ICH/GCP guidelines and 21 CFR.
• Maintained protocol timelines to achieve target objectives.
• Interacted with internal and external working groups to evaluate needs and resources for studies.
• Assisted the data management groups and the project team in the processing of all clinical data by
ensuring the timely collection of other aspects of job-related responsibilities, data and query resolution.
• Worked as an integral team member with respect to quality, integrity and timeliness of projects.
• Motivated site to reach goals. Developed successful, professional rapport with site staff.
• Essential team member on New Drug Application submitted to the FDA.
Molecular Neuroimaging/Institute for Neurodegenerative Disorders 11/2002-1/2007
Certified Clinical Research Nurse Coordinator
• Recruitment, implementation and coordination of Phase I-IV clinical trials involving Parkinson’s,
Huntington’s and Alzheimer’s Disease.
• Project lead for all Huntington Disease clinical trials.
• Project lead for all Phase I Healthy Control clinical studies.
• Determined patient eligibility performed consenting process, responsible for drug accountability.
• Performed all diagnostic procedures including procuring safety labs via venipuncture as well as gaining
intravenous access to administer study drug per manufactures instructions.
• Accurately completed CRF’s both paper and electronic through EDC. Ensured compliance with protocol
by maintaining timelines and possessing a working knowledge of regulatory practices and procedures.
• Created source documents for all clinical studies.
• Documented and reported serious adverse events to both sponsors and IRB’s.
• Developed and implement standard operating procedures for research facility.
• Maintained an enjoyable working relationship with all monitors on all clinical studies.
• Attended investigator meetings in preparation for all clinical studies.
Midstate Medical Center, Emergency Department 12/2001-1/2003
Licensed Practical Nurse
• Assessed and administered emergency care to patients with a broad range of complaints from fractured
bones, patients suffering with asthma attacks to patients experiencing chest pain.
• Skilled in administering I.V. therapy, CPR, defibrillation, physical assessments, removing sutures and
staples and performing emergency medical treatment according to hospital protocol.
• Proficient in patient documentation per hospital guidelines.
Whitney Pediatrics 11/1998-5/2000
Licensed Practical Nurse
• Responsible for the care of pediatric patients and their families.
• Duties included performing triage via telephone, assessing patients on arrival at the office, administering
immunizations and medications and performing routine hearing and vision screening.
• Additional responsibilities including drawing blood, scheduling appointments, ordering all medical
supplies, insurance referrals and keeping the day running smoothly for five physicians.
Saint Raphael Hospital 6/1998-11/1998
Licensed Practical Nurse, Certified Critical Care Nurse
• Responsible for patient care and comfort on the post-operative orthopedic floor.
• Administered pain medication, maintained I.V access, and applied post-operative orthopedic equipment.
• Performed constant evaluation of post-op patients, provided frequent updates to physicians on patient
status, documented patient status per hospital guidelines.
New Haven Ambulance Service 5/1990-5/1992
Emergency Medical Technician
• Skilled in administering life-sustaining treatment to patients in emergency situations.
• Trained to administer I.V. fluids, perform CPR, defibrillation, physical assessment and determined the
appropriate emergency treatment according to medical protocols.
• Effectively relayed patient’s condition to emergency room personnel.
Image Solutions Inc.-Electronic Common Technical Document (eCTD) Training
Drug Information Association (DIA)-Principles of Drug Safety Surveillance
Norton Training Institute-Clinical Research Associate Training Program
Barnett International-Monitoring Clinical Drug Studies
PC, Mac, Excel, Word, Power Point, Visio, Starting Point, Inform, Oracle, Arisg, Argus, MedDRA
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