PATRICIA ANN SIMON RN, MS

847-***-****

aduxk9@r.postjobfree.com

EXPERTISE AND ACHIEVEMENTS

Master's prepared Registered Nurse with 15 years of various hospital clinical experience and17 years of experience in Safety/Pharmacovigilance in a global environment.

Medical & clinical knowledge

Excellent analytical & problem solving skills

Excellent oral & written communication & interpersonal skills

Operates effectively in a team environment

Ability to work under strict deadlines and changing priorities without supervision

Able to multitask and prioritize changing workload on a daily basis

Working knowledge of worldwide safety regulations

Ability to establish priorities and proceed with accomplishing objectives

Ability to proficiency work with a Global Safety Database (e.g., ARISg)

Lead and implemented the Six Sigma approach (measured, analyzed, improved and controlled) to various projects in an effort to reduce process variation to business processes.

EDUCATION

1991-1994 Master of Science in Health Service Administration, College of

St. Francis, Joliet, Illinois

1989-1991 Bachelor of Science in Health Arts, College of St. Francis,

Joliet, Illinois

1981-1984 Registered Nursing Degree, Diploma Program, Evanston

Hospital School of Nursing, Evanston, Illinois

1979-1981 Associate of Arts Degree, Felician College, Chicago, Illinois

Dean’s list - four consecutive semesters

EXPERIENCE

2017 to Present

Author of six Children’s Books (Books for children born with craniofacial differences)

Smile with Simon, Simon and the Buddy Branch, Simon and the Bully, Simon and Patty Go To Camp, Little Leo Underdog to Superdog, and Simon Says Mask On Mask Off

Created website: www.smilewithsimon.org

11/19-6/12/20 Stryker (Sage) Corporation, Cary, Illinois

Senior Specialist, Post Market Surveillance Medical Devices

Facilitate product complaint process by performing safety review to determine seriousness and event resolution.

Prepare and submit expedited drug and medical device reports to US and International regulatory agencies within required timeframe.

Engage external customers in verbal or written communication regarding complaints and/or inquiries.

Respond to customer with investigation findings as requested.

Review and approve customer quality complaint investigations.

Engage internal customers in written and verbal communication concerning internal procedures and regulatory requirements related to complaint handling systems and regulatory reporting.

Facilitate training on product complaint and adverse event reporting requirements.

Monitor and present on monthly quality metrics related to adverse event reporting.

08/16-2/1/17 Baxter Healthcare Corporation, Deerfield, Illinois

Hiregenics Management Systems, Contract Position

Safety Review Specialist, Postmarketing Safety

Part of the cross-functional team performing quality review through the triage, assessment, narrative writing, query generation and quality check of spontaneous, solicited, clinical and literature adverse event reports.

Provide expertise as a health professional by reviewing literature abstracts and articles of Scientific Journals for reporting of case safety reports, risk assessments, and signal detection for all therapeutically aligned products.

Participated in development of training materials and provided training to 3rd Party Vendor from India on how to write appropriate queries to health care professionals seeking follow up information for adverse events.

5/12-1//16 Baxter Healthcare Corporation, Deerfield, Illinois

Safety Review Specialist, Postmarketing Safety

Member of the Safety Operations team within Global Patient Safety.

Captured, evaluated, analyzed, processed and reported adverse events. Member of the cross functional quality control finalization team and literature team member. Trained 3rd Party Vendor from India on Literature case processing.

01/00 -04/12 Abbott Laboratories, Abbott Park, Illinois

12/07-04/12 Assistant Director, Postmarketing Safety

Primary responsibilities included management of Postmarketing Safety’s daily workload to ensure compliance. Lead several cross-functional projects such as Volume 9A, Medication Error, 3RD Party Vendor Training, Career Mapping and Drug Launch Teams. Trained and mentored other Managers.

06/02-12/07 Therapeutic Team Manager for Anti-Viral/Anti-Infective

Case Processing Group, Postmarketing Safety

Manage, lead and developed Anti-Viral/Anti-Infective team of 9-10 Medical Safety Analysts. Performed case triage, prioritized and integrated cases into team workflow to ensure compliance with worldwide regulations and guidelines. Identify, initiate and implemented process and workflow procedure improvements. Analyzed situations to identify problems, and worked proactively with peers to formulate solutions for management discussion. Responsible for the performance review and guidance of team members. Knowledgeable in the literature and Periodic Report generation process. Conducted and coordinated timely training sessions for Clinical/Postmarketing/Product Quality/Affiliates on medication errors (Brazil). Participated in special projects such as Chairperson for E2B Case Processing Team, Member of MedDra Management Committee, and Member of MedDra Coder/Browser Replacement Project.

6/00-6/02 Medical Safety Associate, Postmarketing Safety

Responsible for collecting, assessing, and processing Post-Marketing adverse events which include serious, non-serious, domestic, and foreign adverse events for submission to the FDA and other global regulatory agencies are ensuring compliance with worldwide regulations and guidelines.

Provided training, mentoring & subject matter expert (SME) support for teams and individuals within and beyond Medical Safety Services (MSS) department.

Performed regulatory evaluation and assigned causality and labeledness as applicable; coded cases using appropriate dictionary to search and input data in electronic databases; provided electronic submissions of safety reports (E2B) support to adverse events (AE) process; generated, tracked and resolved adverse event follow-up/distribution correspondence.

9/96-6/00 Kendle (Contract Research Organization), Northbrook, Illinois

Safety Specialist

Opened Chicago Safety Office. Responsible for initial/follow-up and site communication for all serious adverse event reports. Worked closely with Searle Pharmaceutical Company to report SAEs for their investigational COX-2 drug (Celebrex). Reported directly to the Medical Director/Safety Officer located in Cincinnati, Ohio.

1987-1996 Evanston Hospital, Evanston, IL

Staff Nurse

Area of specialty: Maternal Child Health. Over nine years’ experience in providing quality patient care in three separate areas: Labor and Delivery, Post-Partum and Level 1 Nursery.

Speaking Engagements

2017 New York Presbyterian Hospital Keynote Speaker

2017-2022 Children’s Craniofacial Association, Speakers Bureau

2022 Smile Train Speaker Cleft Conference Chicago

2022 Smile Train Speaker Cleft Conference New York (Virtual)

2020-2022 Board Member for Children’s Craniofacial Association (secretary)

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