David Carr
Mannheim,Germany
Summary
An experienced pharmacovigilance expert with over 18 years’ pharmacovigilance experience in both clinical trials and the post marketing phase, gained working for a blue-chip pharmaceutical company, global CROs as well as a medical device manufacturer, seeking to leverage extensive experience in a new leadership role.
Overview
20
20
years of professional experience
Work History
Manager, Pharmacovigilance
Chiltern International
Edinburgh, UK
03.2015 - 11.2018
- Oversee and manage a team of PV professionals and assigned projects
- Tasked with ongoing recruitment of talented PV staff including the building and management of a new PV team in Czech Republic
- Work alongside Budgets and Proposals team providing input into budgets for PV services for prospective projects and attend Bid Defence meetings when required
- Monitor project finances and ensure accurate revenue recognition
- Responsible for provision departmental compliance metrics and attend monthly metrics review meetings, addressing quality issues when required
- Provide training and coaching in order to develop team members, with a focus on quality, consistency and efficiency
- Review and approve Safety Management Plans (SMPs) in accordance with client expectations
- Provide input into departmental processes including SOPs/WPDs
- Act as Project Responsible Person (PRP) for a number of standalone PV projects
- Attend audits, both internal and external when required
- Attend client calls and act as primary point of contact for issues arising on projects within team
Senior Manager, Pharmacovigilance
ICON PLC
Mannheim, Germany
09.2020 - 10.2024
- Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for the assigned products
- Management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations
- Monitor projects to assure company profitability and associated project goals and objectives are being met
- Identification and implementation of process improvements to improve efficiencies
- Provide technical oversight of the generation of project plans such as but not limited to Safety Management Plans (SMP) or SAE Reconciliation plans
- Deliver training on department related topics as well as general company processes and systems to Pharmacovigilance staff
- Maintain familiarity with current industry practices and regulatory requirements that affect services provided by the assigned service area
- Develop company employees to ensure high quality work performance and retention of high quality employees
- Ensure that staff fulfil their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable
- Represent Pharmacovigilance department in audits/inspections
- Provide input into budget reviews for prospective work and represent Pharmacovigilance department in Bid Defence Meetings
Senior Project Manager
PrimeVigilance
Prague, Czech Republic
01.2020 - 08.2020
- Acting as the primary contact point for project-related matters for both the client and PrimeVigilance staff
- Project activities planning
- Coordinating the colleagues working on a project
- Assurance of training of all team members from relevant quality documents, including project-specific documentation
- Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones
- Making sure that all the outputs are delivered in high quality and before the final deadline set up by client
- Reporting the client and the PrimeVigilance management, e.g., preparation of monthly reports, serving as basis for invoicing
- Preparation of Accounting of Services and invoice
Deputy EUQPPV, Line Manager
PVpharm
Almeria, Spain
03.2019 - 12.2019
- Oversee and manage a team of PV professionals and assigned projects
- Responsible for oversight and support to team of PV staff and for allocating resources to projects
- Promote quality achievement and performance improvement throughout the organization
- Has quality oversight and monitors overall compliance and KPIs.
- Monitors processes and workflows and implements process improvements for projects when required
- Coordinate the development, implementation and monitoring of goals, objectives, policies, procedures and systems
- Overview of medicinal product safety profiles and any emerging safety concerns
- Ensure conduct of pharmacovigilance and submission of all pharmacovigilance related documents in accordance with the legal requirements and GVP
- Ensure a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit risk evaluation of a medicinal product
- Provide any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency
- Act as a single pharmacovigilance contact point for the competent authorities in Member States and the Agency on a 24-hour basis and also as a contact point for pharmacovigilance inspections
Principal Pharmacovigilance Officer
Chiltern International
Edinburgh, UK
04.2013 - 03.2015
- Responsibilities were as below for Senior Pharmacovigilance Officer with additional line management duties
Senior Pharmacovigilance Officer
Chiltern International
Edinburgh, UK
07.2012 - 04.2013
- Set up and lead partial and full service complex projects
- Effectively interface with project team, client, and investigators regarding safety activities from project start up through to database lock
- Provide training and mentoring to more junior team members and present at Global PV Meetings when required
- Write or advise on pharmacovigilance sections for protocol and prepare SAE narratives and CIOMS/MedWatch Forms as required
- Discuss, when appropriate with the sponsor or Chiltern Medical team, any issues arising from adverse events reported to Pharmacovigilance
Post Market Surveillance Associate
Vascutek Ltd
Glasgow, UK
03.2010 - 04.2012
- Responsible for all post market surveillance activities relating to medical devices manufactured by Vascutek Ltd
- Ensure timely receipt, assessment and reporting of adverse event reports arising from clinical trials and post market studies in line with quality management system and regulatory requirements
- Author clinical evaluation reports and provide input into technical files/design dossiers when required
- Develop, validate and manage all post market surveillance registries and provide training to relevant Vascutek staff and hospital staff where appropriate
- Conduct audits of clinical trial site data and databases
- Write and submit annual progress reports and final study reports for allocated clinical studies
- Participate in the preparation of clinical trial documentation in line with GCP and company requirements
- Review published literature pertaining to Vascutek products for post market surveillance information on an ongoing basis
Information Scientist
NHS Scotland
Glasgow, UK
01.2010 - 03.2010
- Involved in the review and critical appraisal of information and writing
- Involved in the design, development and implementation of research associated with the decontamination of medical devices
- Preparation of papers and reports for publication including web-pages
- Developed and adapted appropriate questionnaires and databases, analysing, interpreting and reporting findings
Senior Clinical Safety Specialist
PPD
Bellshill, UK
09.2008 - 11.2009
- Primary safety specialist for assigned projects
- Responsible for the day to day handling of SAEs in a timely manner in accordance with SOPs/WPDs and regulatory requirements
- Review safety information for completeness and send follow up queries to trial sites where appropriate
- Promptly feedback any significant safety or regulatory concerns to Pharmacovigilance Manager
- Develop and maintain a co-operative working relationship with project team members
- Attend project team meetings, client meetings, and other appropriate meetings, as required, for assigned projects
- Provide input to SOPs/WPDs generation and revisions
- Produce and review quarterly, periodic and annual safety reports, ensuring these are submitted to appropriate authorities on time
- Responsible for the preparation and attendance of audit meetings
- Involved in the mentoring and training of junior staff
Pharmacovigilance Officer
Sanofi-Aventis
Guildford, UK
03.2005 - 08.2008
- Involved in all aspects of the processing and tracking of adverse events from both clinical trials and from the post-marketing stage
- Assisted in all aspects of case management including triage, narrative writing and database management
- Provide input to and manage safety data exchange agreements with affiliates
- Prioritised and managed own workload to ensure that corporate and regulatory timelines were met for the reporting of pharmacovigilance data
- Followed up all reports of adverse experiences by requesting further information from the reporter, maintaining an accurate paper and electronic audit trail of all actions
- Performed literature articles for relevant Pharmacovigilance data pertaining to drugs marketed by Sanofi-Aventis
- Provide input to signal generation meetings for assigned therapeutic areas
- Involved in the initial and ongoing training of internal staff in the principles of drug safety
Education
BSc (Hons) - Molecular Biology
University of Surrey
Guildford06.2004
Certificate - Basic Clinical Research and GCP Competence
Brookwood International Academy of Healthcare Research
05.2004
Diploma - Higher Education (Science)
University of Glasgow
05.1999
Skills
- Management and Development of Pharmacovigilance Teams
- Project Management
- Knowledge of GCP, pharmacovigilance/drug safety, and regulatory requirements
- Pharmacovigilance Quality and Compliance Oversight
- Proposal and Budget review and management
References
Available on request
Personal Information
- Date of Birth: 10/11/79
- Nationality: British
Timeline
Senior Manager, Pharmacovigilance
ICON PLC
09.2020 - 10.2024
Senior Project Manager
PrimeVigilance
01.2020 - 08.2020
Deputy EUQPPV, Line Manager
PVpharm
03.2019 - 12.2019
Manager, Pharmacovigilance
Chiltern International
03.2015 - 11.2018
Principal Pharmacovigilance Officer
Chiltern International
04.2013 - 03.2015
Senior Pharmacovigilance Officer
Chiltern International
07.2012 - 04.2013
Post Market Surveillance Associate
Vascutek Ltd
03.2010 - 04.2012
Information Scientist
NHS Scotland
01.2010 - 03.2010
Senior Clinical Safety Specialist
PPD
09.2008 - 11.2009
Pharmacovigilance Officer
Sanofi-Aventis
03.2005 - 08.2008
BSc (Hons) - Molecular Biology
University of Surrey
Certificate - Basic Clinical Research and GCP Competence
Brookwood International Academy of Healthcare Research
Diploma - Higher Education (Science)
University of Glasgow
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