Paula Barker work email
- Valid
- Valid
Paula Barker personal email
Paula Barker phone numbers
Professional with 20 years experience in the life sciences industry focused on championing patient safety through establishing quality standards, ensuring regulatory compliance, and supporting efficient systems/operations. Results-driven and resourceful leader who adds value by implementing solutions, building highly effective teams, and forming successful internal/external collaborations to realize goals. Recognized for successful support of FDA inspections, safety system validation/implementation, vendor on-boarding/oversight, and implementation of quality systems.Regulatory Knowledge: FDA, ICH, EMA, HIPAA, "Sunshine Act", False Claims Act
-
Head Of Drug Safety OperationsHalozyme Therapeutics, Inc. Nov 2017 - Aug 2018San Diego, California -
Associate Director, Pv OperationsPharmacyclics, An Abbvie Company Mar 2015 - Nov 2017PV Operations Leader. Built high performing team. Quality and Compliance expertise. Alliance partner collaboration. Vendor management. Met corporate goal saving $26mil over three years. -
Drug Safety And PharmacovigilancePaula Barker Consulting May 2011 - Mar 2015Greater San Diego AreaSupport of Investigational and post marketing activities. SOP development, training, inspection readiness, safety management plans, product launch preparation, vendor evaluation/on-boarding/management, safety data QC/narrative preparation, regulatory intelligence, project management.
-
Training And Compliance ManagerBiogen Jun 2004 - Jul 2010Managed team. Oversaw training strategies and operations, learning systems, annual GCP training, vendors and metrics reporting. Facilitated continuous improvement. Audit/regulatory inspection support. Training quality system implementation. Served as project manager for various training system and SOP initiatives resulting in process improvements and reduction of compliance risks. -
Pharmacovigilance Quality ManagementBiogen Feb 2003 - Jun 2004Managed performance measurement and continuous improvement efforts. Monitored operations. Performed internal audits and risk assessments. Developed SOPs. Implemented a quality management system including training, SOPs/change control, ICSR/PSUR quality review, good documentation practices, 21 CFR Part 11, deviation investigation/CAPA procedures, product complaint/AE procedures and partner agreement compliance.
-
Global Safety ManagerElan Pharmaceuticals Nov 2002 - Feb 2003Responsible for quality review of ICSRs. Developed safety system procedures and data conventions. Facilitated serious AE reconciliation. -
Interim Head Of Regulatory SafetyPfizer Jan 2001 - Aug 2001Managed staff and operations. Facilitated a smooth transition to new organizational structure. Assessed and implemented a new safety system. Developed workflows to facilitate the efficient review and exchange of safety data between sites. -
Sr. Regulatory Safety SpecialistPfizer (Agouron) Jan 1997 - Jan 2001Supervised staff and operations. Performed quality review and audits of safety documentation. Determined ICSR global reporting requirements. Prepared and submitted ICSRs/periodic safety reports in compliance with global regulations and partner agreements. Performed deviation investigations, prepared CAPAs and followed to resolution. Developed validated reports for management, regulators and development partners. Developed SOPs and partner agreements.
Paula Barker Skills
Paula Barker Education Details
-
Health Law -
Business And Management -
Clinical Trials Design And Management
Frequently Asked Questions about Paula Barker
What is Paula Barker's role at the current company?
Paula Barker's current role is Volunteer.
What is Paula Barker's email address?
Paula Barker's email address is pb****@****cyc.com
What is Paula Barker's direct phone number?
Paula Barker's direct phone number is (408) 774*****
What schools did Paula Barker attend?
Paula Barker attended University Of California, San Diego, University Of Redlands, University Of California, San Diego.
What skills is Paula Barker known for?
Paula Barker has skills like Corporate Compliance, Quality Management, Clinical Trials, Cro, Compliance Program Management, Biotechnology, Regulatory Affairs, Change Control, Process Improvement, Validation, Pharmacovigilance, Sop Development.
Not the Paula Barker you were looking for?
-
2hotmail.com, 78gresty.co.uk -
Paula Barker
Cleveland, Oh -
Paula Barker
Lead Financial Service Representative At Bay Area Credit UnionToledo, Ohio Metropolitan Area2huntington.com, bayareacu.com -
Paula Barker
Minneapolis, Mn4vaaeng.com, gmail.com, 4front.biz, nexamp.com1 +176355XXXXX
-
Paula Barker
Dallas, Tx3microfocus.com, yahoo.com, smart.com.ph2 +441635XXXXXX
Free Chrome Extension
Find emails, phones & company data instantly
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial