Curriculum Vitae

Michael Bonett
B.Pharm (Hons.), M.A. Integrated Marketing Communications
(0044/(0)74 68740022/ mbon008@yahoo.com / Born: 07/04/1977)

POSITIONS HELD
UK, Wokingham
January 2016 Present, J&J Medical, Quality and Regulatory Specialist Supply Chain
Quality Assurance (GDP, Suppiler Audits, Documentation Review, Quality Agreements)

Netherlands
March 2014 Dec 2015, UPS Quality Assurance and Regulatory Affairs Manager EMEA
Regulatory Affairs (EMEA Regulations, Improvement of Compliant Quality Systems)
Public Affairs (Healthcare Regulations EU, National, Medical Devices, Pharmaceuticals)
Quality Management (Healthcare Contract Logistics Supply Chain Hungary and Italy)
Quality Assurance Enterprise (Small Package, Freight - Certification, Audit, Analysis)
Business Development (Support with responses to requests for quotes/implementations)
Participation in Integration Projects for Acquisitions (Italy, Hungary, UK)

UPS Supply Chain Solutions - Regulatory Affairs Manager Europe

2011 March 2014 (3 years)
Supporting senior management with research into regulations in different European countries
to ensure that UPS complies with regulatory developments
Dissemination of new government licensing and reporting requirements, provide regulatory
direction and research the applicability of regulations.
Setting-up of a GMP re-work facility, upgrade the GDP license, agency queries
Provide appropriate training to colleagues on GMP/GDP, procedures
Keep-up-to-date external regulatory documents (WHO, ICH, EMEA, EU, ISO)
Assist Responsible Person with follow up on procedures and general quality system (audits,
improvement plans, documentation system, CAPA, ISO 9001)
Interact with Global, regulatory affairs, operations, business development, HR

UPS Supply Chain Solutions - Quality Assurance Supervisor

March 2010 April 2011 (1 year 2 months)
All aspects of Quality Assurance: Audits, Documentation, CAPA, Training Management, Validation.
ISO 9001:2008. EU GDP. Set-up of GMP area.

Pharmacovigilance Consultant, Interdos Pharma

May 2009 December 2009 (8 months)
Research of Literature.
Writing large detailed technical safety reports (PSUR)
Processing of single safety reports and product complaints.
Database Management.
Monitoring Safety of Pharmaceutical Medicinal Products.
Writing Quality documents: SOPs and Training Manuals.
EU European Medicines Agency Eudravigilance adverse drug reaction reports processing and
product registrations.
MedDRA coding of medical terms.
Summary of Product Information Characteristics (SPC) updates.

Centocor, Senior Pharmacovigilance Associate, Leiden

December 2007 until December 2008
Maintaining effective communication internally, globally, with local subsidiaries & marketing
partners within the organisation & with European regulatory authorities
Writing up of responses to queries from EU/EMEA/EFTA regulatory authorities
Operation in the complexity of the pharmacovigilance process within strict time-lines
Submission of medical documents such as Periodic Safety Update Reports
Management of reporting of post marketing and clinical trial adverse event reports
Provision of medical input in the review of reports and documents
Writing up of standard operating procedures and continuous development of
pharmacovigilance systems in order to remain compliant with European pharmacovigilance
requirements
Quality systems management, improvement & harmonisation of processes & operations
between EU & US reporting group, within J&J global organization and operating companies

Development of, delivery and management of training and training programs

Assistance and participation in internal audits and health authority inspections
http://www.centocor.com/centocor/index.html

Until November 2007, Medicines Evaluation Board, Pharmacovigilance Assessor,

The Hague
Medical & quality assessment of documents such as Product Information Updates, Periodic
Safety Update Reports, Description of Pharmacovigilance Systems & Risk Management
Plans
http://www.cbg-meb.nl/uk/overcbg/acbg.htm

Malta
Project team (Medicines Regulatory Unit) to set-up a Medicines Authority, then
within the Medicines Authority itself.
Malta Regulatory Authority, Sep 2000 May 2006, Quality Assessor/Pharmacist
Assessment of product information according to EU regulations
Promotion (e.g. articles, presentations) of a national adverse drug reporting (ADR)
Setting up and maintenance of a national ADR Database and connection to the European
Eurdavigilance network and World Health Organisation ADR network
Processing, assessment & follow-up of spontaneous and clinical trial ADR reports
Design and implementation of a quality system to manage variations to product information
Conduction of training and participation in auditing team
Involvement is setting up systems to comply with EU directives requirements for clinical
trials and advertising of medical products
http://www.medicinesauthority.gov.mt/

Setting-up of the Maltese Medicines Authority through implementation of EU and national

legislation and participation in EU training provided by UK and Ireland
Information dissemination to stakeholders (industry, unions, professionals)
Establishing systems and writing-up of standard operating procedures (SOPs)
Attendance to Pharmacovigilance & Quality Working Party Meetings at EMEA
http://www.doi.gov.mt/EN/press_releases/2001/11/pr1806.asp

University of Malta, Jan 2003 - Jun 2003, Part-time Lecturer

Co-ordination, curriculum development and delivery of Regulatory Affairs training and
Pharmacovigilance lectures
http://www.um.edu.mt/

EDUCATION
PHARMACY (BACHELOR)
1995 to 2000

University of Malta, Faculty of Medicine & Surgery

Bachelor of Pharmacy (Honours) 2nd Class

Specialisation: Clinical Pharmacy. Dissertation: Preparation and Evaluation of Glycerine Suppositories

COMMUNICATIONS (MASTERS)
2002 to 2004

University of Malta, Centre for Communication Technology

Masters Degree in Integrated Marketing Communications

Specialisation: Marketing. Dissertation: Attitudes of Pharmacists towards ADR reporting

TRAINING COURSES
Building Relationships, UPS, June 2013
Develop Yourself, Deliver Results, UPS, Sep 2011
GMPs in Storage, Transportation and Cold Chain, ECA, Mar 2012
Pharmaceutical GMP, DBA, Dec 2010
Good Distribution Practice Inspection, MCA, Nov 2002
MedDRA Structure and Functions, MSSO, SEP 2005
EudraVigilance User Training Course, EMEA, OCT 2004
Pharmacovigilance/IT study visit at the Irish Medicines Board (IMB), JUN 2002
Internal QMS Auditor Training Course, IQA Services Ltd., DEC 2004
Pharmaceutical Regulatory Affairs and Legal Issues, University of Malta, AUG 2001
Twinning Project (MHRA/IMB) Training
Communication, & Presentation Skills, Effective Meetings & Time Management, EU
Marketing Authorisation Applications, Quality Systems, & Pharmacovigilance

ADDITIONAL EDUCATION
COMPUTER STUDIES
Computer Literacy, Word Processing
MS ACCESS, Introduction
SPSS, Introduction

University of Cambridge
Staff Development, Office of Prime Minister
University of Malta

MANAGEMENT
Managing Change, People
The Economic Environment
European Union Studies

Malta Institute of Management

Maastricht School of Management
Staff Development, Office of Prime Minister

EUROPEAN UNION MEETINGS

Pharmacovigilance Working Party JAN 2002, MAR 2002, MAY 2003
Good Regulatory Practices/Quality Management Systems MAY 2002, JAN/DEC 2003
Eudravigilance Joint Implementation Group Meeting, DEC 2003
EMEA CHMP Safety Working Party DEC 2005, FEB 2006

WHO CONFERENCES

Drugnet - Network of Drug Regulatory Authorities - Diminishing Risks in Products and

Practices (participated as speaker) Malta, 17-18 June 2002
Pharmacovigilance Annual Meeting, Dublin, Oct 2004

PUBLICATIONS
A National Adverse Drug Reaction Reporting System for Malta, Malta Medical Journal, Oct
2004.

MEMBERSHIP OF PROFESSIONAL ORGANISATIONS

Malta Institute of Management, since Feb 2001

Drug Information Association, since Nov 2005

ADDITIONAL EXPERIENCE

Community Pharmacy: Qawra Pharmacy, Blossoms Pharmacy

Animator/groupleader/tourguide part-time at English International Language schools
(Sprachcaffe Club Village, European School of English, EF international)
Playing guitar in various music groups / playing in a waterpolo team

LANGUAGES
English:
Maltese:
Italian:
French:
Dutch:
German:

Fluent, excellent reading and writing skills

Fluent, mother language
Fluent, good reading and writing skills
Basic speaking, reading and writing skills
Basic speaking, reading and writing skills
Basic phrases

INTERESTS
Travelling, Reading, Guitar/Music, Gym, Swimming/Fishing/Diving