Mary Ellen Anders, BSN, RN, MBA
Pharmacovigilance Project Lead at ProPharma Group- Claim this Profile
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Bio
LinkedIn User
I would like to recommend Mary Ellen Anders as a valuable resource. I have worked with Mary Ellen over the past 4 years in the Pharmacovigilance industry. I consider her a respected colleague and co-worker. She possesses great critical thinking and organizational skills and is detailed oriented. She is a great team player, always willing to help others and was a mentor for the new members to the team. She also work on several project teams including CAPA. She communicates well with both internal and external customers. She would be a tremendous asset to any organization. March 29, 2013
Mary Friese
Mary Ellen is an accomplished and motivated leader with an extensive clinical nursing background that includes experience in all aspects of Post Market Surveillance. She is very focused on compliance and continuous improvement efforts with proven ability to drive quality and business efficiency.
LinkedIn User
I would like to recommend Mary Ellen Anders as a valuable resource. I have worked with Mary Ellen over the past 4 years in the Pharmacovigilance industry. I consider her a respected colleague and co-worker. She possesses great critical thinking and organizational skills and is detailed oriented. She is a great team player, always willing to help others and was a mentor for the new members to the team. She also work on several project teams including CAPA. She communicates well with both internal and external customers. She would be a tremendous asset to any organization. March 29, 2013
Mary Friese
Mary Ellen is an accomplished and motivated leader with an extensive clinical nursing background that includes experience in all aspects of Post Market Surveillance. She is very focused on compliance and continuous improvement efforts with proven ability to drive quality and business efficiency.
LinkedIn User
I would like to recommend Mary Ellen Anders as a valuable resource. I have worked with Mary Ellen over the past 4 years in the Pharmacovigilance industry. I consider her a respected colleague and co-worker. She possesses great critical thinking and organizational skills and is detailed oriented. She is a great team player, always willing to help others and was a mentor for the new members to the team. She also work on several project teams including CAPA. She communicates well with both internal and external customers. She would be a tremendous asset to any organization. March 29, 2013
Mary Friese
Mary Ellen is an accomplished and motivated leader with an extensive clinical nursing background that includes experience in all aspects of Post Market Surveillance. She is very focused on compliance and continuous improvement efforts with proven ability to drive quality and business efficiency.
LinkedIn User
I would like to recommend Mary Ellen Anders as a valuable resource. I have worked with Mary Ellen over the past 4 years in the Pharmacovigilance industry. I consider her a respected colleague and co-worker. She possesses great critical thinking and organizational skills and is detailed oriented. She is a great team player, always willing to help others and was a mentor for the new members to the team. She also work on several project teams including CAPA. She communicates well with both internal and external customers. She would be a tremendous asset to any organization. March 29, 2013
Mary Friese
Mary Ellen is an accomplished and motivated leader with an extensive clinical nursing background that includes experience in all aspects of Post Market Surveillance. She is very focused on compliance and continuous improvement efforts with proven ability to drive quality and business efficiency.
Credentials
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Giving and Receiving Feedback
LinkedInDec, 2022- Nov, 2024 -
Achieving High-Performance During Times of Stress
LinkedInOct, 2022- Nov, 2024 -
Leading and Motivating People with Different Personalities
LinkedInSep, 2021- Nov, 2024 -
Leadership Fundamentals
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Leading Yourself (2017)
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Operational Excellence Foundations
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Speaking Confidently and Effectively
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Communicating with Empathy
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Communication Foundations
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Creating a Positive and Healthy Work Environment
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Developing Your Emotional Intelligence
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Increase Visibility to Advance Your Career
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How to Manage Your Manager
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Learning Personal Branding
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Management Tips
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Own Your Voice: Improve Presentations and Executive Presence
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Time Management: Working from Home
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Avoiding Phishing Scams
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Betty Liu on Career Success
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Communication Tips
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Enhancing Resilience
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How to Manage Feeling Overwhelmed
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How to Use LinkedIn Learning
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Experience
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ProPharma
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United States
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Business Consulting and Services
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700 & Above Employee
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Pharmacovigilance Project Lead
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Jan 2021 - Present
Responsible for directional leadership of Pharmacovigilance (PV) clients that are contracted for PV services, which includes collaborating with internal and external customers on standard service offerings, limited oversight for research, implementation and management of PV services, ensure compliance with US, Canadian, European PV requirements, and SOPS for investigational and marketed products.
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Pharmacovigilance Senior Specialist - Literature
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Jul 2017 - Jan 2021
Responsible for performing literature citation/abstract review to identify articles of interest and determine reportability. Manage pharmacovigilance cases which includes case and event assessment and coding. Perform Siebel assessment review. Act as client contact for case management and reporting functions. Maintain distinctive quality and commitment as the operating philosophy in carrying out all processes. Continually seek out ways to enhance customer service experience both internally and externally.
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Pharmacovigilance Senior Specialist
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May 2016 - Jun 2017
Responsible for the management of pharmacovigilance cases through follow up call intake, documentation and case processing. Perform processing of adverse events, conduct follow up, write narratives in accordance with internal guidelines and safety regulations. Responsible also for the development of training materials, conducting training presentations, and on the job training for call center, medical information, and pharmacovigilance staff.
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Product Analyst / Product Surveillance
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Jan 2016 - May 2016
Responsible for processing product complaints for the Urology and Pelvic Health Division, product quality data analysis / trending. Responsible for processing product complaints for the Urology and Pelvic Health Division, product quality data analysis / trending.
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Boston Scientific
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Systems Coordinator
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Aug 2015 - Jan 2016
Responsible for the coordination of global field action activity. This includes supporting communication development and execution with stakeholders, customer communication tracking, development of regulatory body communication, inventory tracking, regulatory file maintenance, and interfacing with other functions and company sites involved in field action management.Assist with product quality data analysis/trending, change orders, and training plan audits. Responsible for the coordination of global field action activity. This includes supporting communication development and execution with stakeholders, customer communication tracking, development of regulatory body communication, inventory tracking, regulatory file maintenance, and interfacing with other functions and company sites involved in field action management.Assist with product quality data analysis/trending, change orders, and training plan audits.
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Quality Systems Coordinator
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Oct 2014 - Aug 2015
Responsible for the coordination of global field action activity. This includes supporting communication development and execution with stakeholders, customer communication tracking, development of regulatory body communication, inventory tracking, regulatory file maintenance, and interfacing with other functions and company sites involved in field action management. Responsible for the coordination of global field action activity. This includes supporting communication development and execution with stakeholders, customer communication tracking, development of regulatory body communication, inventory tracking, regulatory file maintenance, and interfacing with other functions and company sites involved in field action management.
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Smiths Medical
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United States
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Medical Equipment Manufacturing
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500 - 600 Employee
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Senior Global Post-Market Surveillance Specialist Clinical Marketing and Scientific Affairs
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Jun 2013 - Nov 2013
Responsible for the development, implementation, and management of proactive Post-Market Surveillance and Product Stewardship programs across all product franchises, design authorities, and manufacturing sites globally. Responsible for the development, implementation, and management of proactive Post-Market Surveillance and Product Stewardship programs across all product franchises, design authorities, and manufacturing sites globally.
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Baxter International Inc.
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Safety Review Specialist
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Oct 2009 - Feb 2013
I reported adverse drug events to regulatory authorities.
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Product Surveillance Quality Associate III
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Oct 2005 - Oct 2009
I investigated and reported adverse events with devices to the regulatory authorities.
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Lake Forest Hosptial Home Health Care
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Gurnee, Illinois
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Clinical Nurse Educator/IT Trainer
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2004 - 2005
Provided clinical and IT training to a multidisciplinary team of 40. Provided clinical and IT training to a multidisciplinary team of 40.
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Home Health Care Staff Nurse
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1999 - 2004
Provided home health care nursing services to patients. Provided home health care nursing services to patients.
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Hawthorn Schools
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Vernon Hills, Illinois
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Substitute Teacher/Substitute School Nurse
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1998 - 2001
Served as a substitute teacher and school nurse to elementary and junior high children. Served as a substitute teacher and school nurse to elementary and junior high children.
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Staff Builders
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Park Ridge, Illinois
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Home Health Care Staff Nurse
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1994 - 1997
Provided patient care to patients in their homes. Provided patient care to patients in their homes.
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Surgical Intensive Care Staff Nurse
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1991 - 1994
Surgical Intensive Care Surgical Intensive Care
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Cardio-Thoracic Intensive Care Nurse
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1987 - 1991
Cardio-Thoracic Intensive Care Cardio-Thoracic Intensive Care
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UI Health
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United States
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Hospitals and Health Care
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700 & Above Employee
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Cardio-Thoracic Intensive Care Nurse
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1983 - 1987
Cardio-Thoracic Intensive Care
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Surgical Step Down Unit
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1982 - 1983
Critical care patient care.
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Education
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2006 - 2008
University of Phoenix
MBA, Management -
1978 - 1982
University of Illinois at Chicago
BSN, Nursing -
1977 - 1978
Triton College
Pre-professional
Community
