Valarie Paquin

*** ****** ******* ***** *******, GA 30024

470-***-**** adculk@r.postjobfree.com

Regulatory Compliance Coordinator

A Recognized Expert in Regulations and Compliance in a Pharmaceutical Setting

Experienced Medical Information professional Pharmacovigilance and with a demonstrated history of working in the Pharmaceuticals industry. Skilled in GxP, Corrective and Preventive Action (CAPA), Complaints, Quality Control, Quality Assurance, Training, Presentation and direct interactions with Health Authorities, Health Care Professionals and the general public.

CORE COMPETENCIES

Compliance Assurance Regulatory Knowledge Customer Relationships Quality Assurance

Team Management Effective Communication verbal and written Interpersonal Skills Process Improvement Drug Process GCP/ICH Guidelines Clinical Trial Process Time Management Highly Organizational Skills Regulatory Submission Documentation (CTA, NDS, SNDS, ANDS, CTD, and QOS) Documentation Adverse drug reaction reporting FDA auditing Review of DHR/DMR files detailed orientated Adobe MS Office applications Draw and interpret bar graphs and charts Detailed Oriented

Accuracy Administrative Support Clinical Research Clinical Trial Collaboration Compliance

EXPERIENCES AND ACHIEVEMENTS

Quest Diagnostics, Tucker, GA May 2018-October 2018

Forensic Scientist

Responsible for all aspects of testing of donor specimens including specimen preparation and instrument operation. Maintaining chain of custody of forensic specimens and follow approved sample handling procedures and proper documentation. Verifying performance of all new reagents and ensuring required calibrators and quality control samples are following departmental SOP procedures.

Atlanta, GA April 2017-Feb 2018

Volunteer

Volunteer at Settles Bridge Elementary as a Room mom for two years requiring exceptional communication skills and organizing skills. Able to solve problems as they arise to make sure everything runs smoothly

Organizing events and being a leader during field trips

Helped with boy scouts by leading them during popcorn sales

CP Medical, Norcross, GA February 2017-April 2017

Quality Assurance (Contract Position)

Accepted a contract to investigate and close the backlog of quality complaints

A broad knowledge of medical device and quality systems regulations

Extensive experience with researching and solving quality complaints using CAPAs, NCMRs and DHR/DMR reviews

Retain the knowledge and ability to develop and administer management information systems to audit quality systems for deficiencies

Extensive reporting on complaint metrics while reviewing and following-up issues

Researched, investigated and closed over 860 quality complaints in two months

Printed, scanned and filed completed quality complaints

Assisted engineers performing an internal audit

Assisted the regulatory affairs department completing a Health hazard assessment and retrieving any documents that were required

Atlanta, GA October 2011-February 2017

Immigrated to the United States of America, while waiting for my green card took time to care of my family. Ready to enter the workforce.

Apotex, Inc., Toronto, Ontario November 2001 – September 2011

Clinical Site Technician April 2011 – September 2011

Supported with the FDA audit by obtaining quality documents required and other requirements.

Played a key role in a multi-disciplined team of healthcare providers tasked with providing timely support for Apotex products by serving as the departmental contact for all issues relating to Health Canada’s Special Access Program (SAP).

Fostered positive relationships with internal and external stakeholders through the use of expert interpersonal and communication skills.

Ensured the high level of integrity and security for the Pharmacy Vault contents by regularly assessing current strategies and operations to locate any areas of improvement.

oProvided archival control for Clinical Test Articles.

Minimized any chance of mistake or false results through the regular maintenance and calibration of clinical equipment and the transfer of biological samples.

Medical Information Coordinator April 2006 – April 2011

Processed and reported adverse drug reactions (ADR) reports in compliance with Pharmacovigilance regulations and relevant ICH guidelines

Prepared and submitted expedited case reports to Regulatory Authorities around the world in compliance with Pharmacovigilance regulations and ICH guidelines

Monitored the status of complaints during the investigation process and followed up with QA personnel to ensure timely investigation

Reviewed medical literature

Responsible for the Special Access Programme

Reviewed product literature

Prepared monthly report

Responsible for the timely response regarding all patient complaints received by the department

Responded to drug information requests

Interacted with health care professionals, consumers, and affiliate offices during investigation of all case reports

Remained up to date with all new policies regarding Canadian Food and Drugs Regulations as well as all relevant guidelines.

Assisted regulatory affairs with submissions and provincial licensing when needed

Assisted with proof reading patient information leaflets and well as labels

Maintained change control activities for the sales and marketing division of the business

Responsible for monthly VP/CEO reports used to account for incidents regarding adverse drug reactions (ADR’s)/Quality complaints (QC) and general inquiries.

oRaw reporting data was analyzed to provide focus items for senior leadership.

Additional reporting was provided to Health Canada for the Special Access Program.

Able to work with various departments to acquire information necessary to resolve customer inquiries and management escalations.

Administrator – Professional Affairs May 2003 – April 2006

Provided responses to requests for information from both internal and external sources. Played a key role in the preparation of PowerPoint presentations.

Coordinated the logistics for event tracking and deliverables concerning multiple ongoing projects.

oUtilized time management skills to ensure all goals were met and delivered within the tight time constraints.

Representative – Order Process November 2001 – May 2003

Handled high volumes of inquiries and requests via telephone to ensure positive customer and company experiences. Oversaw all case study requests sent to the customer service from Drug Information. Served as the key contact for drug recall enquiries while managing all associated returns.

Due to excellent level of work and understanding of the company’s goals, promoted from a contract position to a permanent position within 3 months.

Maximized overall awareness for the order desk concerning the current status of all agents by initiating an innovative policy change.

Created a more effective and even distribution for all electronic requests received from sales representatives.

EDUCATION

Graduate Certificate, Pharmaceutical Regulatory Affairs and Quality Operations

Seneca College, Toronto, Ontario, 2007

Graduated with honors.

Through studies of regulatory compliance in Canada and in other areas of the world, I received experience completing drug and medical device submissions.

Bachelor of Science, Biochemistry, Carleton University, 1999

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