Sharon Kay Richardson, B.S. Pharm.
1145 North Museum Road, #204
Vernon Hills IL 60061
 
Objective: To obtain a position in drug safety or medical information in a
forward looking pharmaceutical or biotechnology company that allows for
continuing growth and development, but also encourages creativity and
advancement. 

Experience:

Astellas Pharma US.
Manager Periodic Reports
May 2008  *  November 2008

 *  Knowledge of FDA adverse event regulations, Astellas policies/procedures,
and Astellas Global requirements for adverse event reporting.
 *  Authors PADERs, PSUR
 *  Participates in the preparation of other periodic reports, such as, PSUR and
NDA Annual Reports.
 *  Working with the safety associate, resolves issues related to evaluation of
adverse events.
 *  Conducts safety-related analyses as and when needed.
 *  Communicates with Clinical Studies personnel and Scientific Liaison
regarding issues related to medical evaluation of safety reports.
 *  Assists in trend analysis of adverse event frequency, including reporting
rates and data analysis.
 *  Participates in special safety projects such as pregnancy and other
registries, safety white papers.
 *  Proficiently access the global safety database to extract, review, and
confirm data applicable to periodic reports or safety analysis. 
 *  Establish and maintain professional relationships while collaboratively
interaction with intra/interdepartmental colleagues. 
 *  Member of Global Working Group for Pharmacovigilance including designing new
template and SOPs for incorporation for Volume 9A

Bristol Myers Squibb
Drug Safety Scientist
October 2006  *  December 2007

 *  Coordinate the compilation and preparation of required aggregate reports
(i.e. PSUR, PADER, QSUSAR, ASRs and Ad Hoc reports). ( Supervise and participate
in the preparation of aggregate report and Ad Hoc reports as required including
health authority request, internal request, Type II labeling change and more,
 *  Collaborate with a multi-discipline team (Global Clinical Development,
Global Regulatory Sciences, and Pharmacovigilance Plans) at all stages of a
product life cycle, including providing medical assessments for these aggregate
reports. Formulate appropriate and timely responses to queries from internal and
external customers.
 *  Utilize medical writing skills to product accurate, concise, medically sound
aggregate reports and Risk Management Pharmacovigilance plans suitable for
submission to health authorities as necessary. I have written, in coordination
with the epidemiology department, four new EU Risk Management Plans in 2007. 
 *  SOPS and working practice documents necessary for the training and
assessment of new safety scientists, Medical Safety Physicians, Regulatory and
Clinical Trials department.
 *  Utilize strong teamwork skills to ensure that processes, procedures and best
practices are consistent across Global Pharmacovigilance and Epidemiology (GPV&E)
and that regulatory requirements are met in a timely manner with high quality.
 *  Utilize prioritization skills, the ability to multi-task, and flexibility to
meet changing business priorities.
 *  Maintain a strong skill set and working knowledge of the GPV&E Safety
Database (CARES), CARA/PRISM, and I-Review, and is able to query independently
the system to support the Aggregate Reports Scientist role. 
 *  Maintain filing system integrity for report hardcopy. Contribute to the
improvement of electronic safety database and filing system, and working to come
up with ways of making aggregate databases more consistent in look and
information provided
 *  Represent Drug Safety management and interests at interdepartmental and
inter-company meetings 
 *  Establish a good working relationship with associated groups, especially
clinical trials, project management, medical writing, regulatory affairs, legal,
and development/ marketing partners 
 *  Apply sound analytical thinking and database query skills to gather,
summarize and evaluate critical information in a timely manner. Assess individual
adverse event report for seriousness, labeling status and relatedness
 *  Maintain a strong knowledge of regulations, processes, SOP's and Work
Instructions as well as conventions, to ensure all safety information is
accurate, integrated, and current and submitted within regulatory timelines. 
 *  Monitor Drug Safety staff compliance with assigned projects
 *  Follow-up adverse event reports according to SOP Conduct internal quality
assurance checks on cases entered in the safety database and spreadsheets.
 *  Document product complaints and assist QA in responding to complaints.
 *  Enter information into Professional Services database and produce monthly
reports from the database
 *  Utilize medical, scientific and clinical knowledge in reviewing safety
related documents (ex. protocols, investigator brochures, product labels,
relevant source documents) and can incorporate key concepts to clearly present
the reported events and in turn maintain patient safety.
 *  Continuously enhance skills through a willingness to learn and by exchanging
best practices with team members.
 *  Seek to contribute actively to process improvement.
 *  Conduct internal quality assurance checks on cases entered in the safety
database and spreadsheets. 

Premier Research Group (formerly known as SCIREX Corporation) 
Drug Safety Manager-Medical Management and Drug Safety Department
June 2006- September 2006

 *  Liaison between Clinical Development/Clinical Research Department, Medical
Management and Drug Safety Department to assure consistent and complete
processing of Adverse Event Reports according to ICH and FDA Guidelines
 *  Perform Individual Case Processing and Quality Assurance Processing for
Individual Case Safety Reports. Follow-up adverse event reports according to SOP
 *  Knowledge of Federal Regulations pertaining to dissemination of medical
information and processing product complaints.
 *  Enter information into Professional Services database and produce monthly
reports from the database
 *  Develop SOP's and Working Practice Documents for the processing of Clinical
Drug Safety Reports
 *  Interact with client corporate representatives and external clients to
discuss individual cases management, clinical trial management and case follow up
through resolution. 
 *  Represent Drug Safety management and interests at interdepartmental and
inter-company meetings. 
 *  Writing of safety narratives and safety assessments prior to submission.
 *  Apply sound clinical judgment to case assessment and IND Safety Report
preparation
 *  Contribute to the improvement of electronic safety database and filing
system,
 *  Ensure the accuracy and completeness of Adverse Event reports and support
information provided to Pharmacovigilance. Maintain filing system integrity for
report hardcopy. Follow-up adverse event reports according to SOP
 *  Assist in writing of SOP's, working practice documents, training of clinical
and safety employees
 *  Assessing and processing narratives for Adverse Experience Reports regarding
Pre-FDA and Post-FDA approved products through the proprietary software. 
 *  Assess individual adverse event report for seriousness, labeling status and
relatedness
 *  Assist in preparation of Drug Safety procedures for clinical protocols for
phase II through post-marketing studies, including data entry, writing
narratives, completing MedWatch or CIOMS forms, completing PSUR and Yearly FDA
Annual Reports as well as contributing to the safety profiles used on
Investigational Brochures and Protocol Writing.
 *  Develop Metrics for data analysis and quality analysis, data case
reconciliation between clinical and drug safety databases, and lock of clinical
databases. 
 *  Prepare standard and ad hoc safety reports as required. Assist in the
maintenance of adverse event dictionary.
 *  Contribute to training of Drug Safety and Clinical Affairs Staff Train,
coach and develop lower level Drug Safety Staff, including performance
evaluations, safety training enhancement and assist in training as required by
other departments

Managed Clinical Solutions
Contract Safety Specialist for Merck (short-term contract) 
August 2005 through May 2006

 *  Vaux litigation specialist. High volume position of data input and narrative
writing. Cases required exceptional writing skills, intercommunication skills and
working across a team of many other safety specialists and supervisors.
 *  Perform Individual case processing for Worldwide Product Safety and
Epidemiology for large post-marketing legal project including the process of
legal medical records and extensive medical records. 
 *  Management of large caseloads, up to 25 daily, requiring strong organization
skills, quick assessment and triaging of cases and knowing what information is
required to go to each individual country.
 *  Ensure the timely processing of all cases (non-serious and serious) adverse
events within a ten-day period. 
 *  Assess individual adverse event report for seriousness, labeling status and
relatedness. Follow-up adverse event reports according to SOP
 *  Interact with a large team of adverse safety specialists. Serve as resource
to and supervise Drug Safety Specialists and Coordinators. Contribute to training
of Drug Safety and Clinical Affairs Staff. 
 *  Establish a good working relationship with associated groups, especially
clinical trials, project management, medical writing, regulatory affairs, legal,
and development/ marketing partners 
 *  Supervise and participate in the preparation of aggregate reports
 *  Enter information into Professional Services database and produce monthly
reports from the database
 *  Conduct internal quality assurance checks on cases entered in the safety
database and spreadsheets. Monitor Drug Safety staff compliance with assigned
projects
 *  Maintain filing