Lynn Dunlop
Kilmarnock,East Ayrshire
Summary
Seasoned Product Safety & Pharmacovigilance professional with expertise in drug and device safety monitoring within clinical trials. Manages the adverse event case processing lifecycle, ensuring compliance with global regulations, including ICH GCP. Drives process improvements and maintains quality control. Aims to leverage experience to advance AI integration in adverse event processing and regulatory reporting.
Overview
1
1
Language
1
1
Certification
27
27
years of professional experience
Work History
Associate Director, Safety & Pharmacovigilance
Syneos Health
05.2022 - Current
- Acts as an interface between the company, customers, vendors, and other departments in the area of safety and pharmacovigilance.
- Provides operational oversight of functional teams and projects.
- Monitors quality of work and efficiency of team members within contracted scope of work and Safety Management Plan; discussed below-target project goals with senior safety management to identify solutions.
- Oversees projects where Safety and Pharmacovigilance are the primary services
- Reviews project budgets and expenses; ensures all project-related contractual and budgeted tasks are upheld and performed.
- Works with Finance to ensure appropriate customer invoicing, where required.
- Provides customers with scheduled project updates and reports and acts as a point of contact for customers
- Coordinates with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues
- Participates in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
- Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan.
- Evaluates processes for improvements in efficiency and effectiveness, recommending changes and participating in development of departmental functions and technology.
- Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and customer meetings.
- Reviews, advises, and approves Safety portions of proposals; ensures wording adequately reflects the scope of work for Safety and Pharmacovigilance.
- Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form
- Oversees resourcing needs/issues for Safety services and escalates to senior management as necessary.
- Maintains understanding and ensures compliance of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practice (GCP), ICH guidelines, GVP modules and drug development process
- Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions.
- Executes additional assigned tasks as directed by management to support team objectives. related duties as assigned.
Safety & PV Project Delivery Manager
Syneos Health
12.2020 - 04.2022
- Ensured all project deliverables meet the internal and external customers expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments
- Ensures that individual project targets and customer needs are met, services are provided with the highest quality standards, and policies and procedures are followed. Contributed to change initiatives across and within the SPVG department.
- Provided oversight of all project SPVG deliverables, which encompasses all activities throughout the duration of the project/program.
- Day to day SPVG operational management and execution of all SPVG project deliverables
- Evaluated financial performance and budget to maintain project profitability and address discrepancies promptly.
- Developed detailed project/program specific Safety Management Plans and provided review of other project plans as applicable
- Ensured adherence to and monitors project/program-specific key performance indicators (KPIs)
- Developed plans in accordance with Standard Operating Procedures and/or client -scoped process. Complied with all controlled document requirements and other requirements to ensure quality deliverables
- Reviewed the SPVG budget with the functional leads, project PM, and SPVG BU Controller against project milestones and budget to ensure project profitability. Took corrective measures where necessary to keep project in line with budget.
- Monitored backlog for assigned projects on a monthly basis to confirm accurate reflection of work to be completed
- Used recognized tools for planning and management of scope, timeline and resources; Ensured that minimum hours are used for tasks.
- Identified best practices and initiated process improvement initiatives to enhance project delivery and operational efficiency
- Provided mentorship to key SPVG project team members to ensure competency in project-specific responsibilities. on project/program specific tasks and a working knowledge of the project/program assigned
- Participated in audits/inspections and ensures inspection readiness at all times. Participates in quality investigations and implementation of corrective and preventive actions.
- Maintained understanding of and ensured compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, project/program plans and the drug development process.
- Ensured all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Customer requirements (clinical studies/programs)
Safety & Pharmacovigilance Program Delivery Lead
Syneos Health
06.2019 - 11.2020
- Provided Safety Lead function for assigned projects
Senior Safety Specialist
Syneos Health
04.2018 - 06.2019
- Prepares a Safety Management Plan.
- Coordination of workload /workflow.
- Review of project performance metrics including quality parameters
- Manages systems for receipt and tracking adverse events (AE)
- Processes AEs according to Standard Operating Procedures (SOPs), and project specific safety plan
- Triages AEs; evaluates AE data for completeness, accuracy and regulatory reportability.
- Enters AE data into safety database.
- Performs Quality Control (QC) of entered data
- Codes events, medical history, concomitant medications, and laboratory tests.
- Compiles complete narrative summaries.
- Discerns what information requires querying and interacts closely with CRAs. investigative site personnel, and customer representatives until all follow-up information is obtained and queries are satisfactorily resolved.
- Generates reports to the customer and regulatory authorities; ensures timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Coordinates with data management staff reconciliation of safety data between the clinical and safety databases.
- Distributes all required periodic safety reports
- Ensures correct archival of project setup and closure documentation
- Maintains current professional knowledge in fields of safety management, coding, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing value added expanded company services
- Provides input to senior departmental management regarding ways to ensure adherence to relevant procedures/regulations, ways to improve work efficiency and maintain customer satisfaction.
- Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines
Safety Specialist II
Syneos Health
06.2016 - 03.2018
- Conducted adverse event management for assigned projects
Senior Safety Specialist
INC Research
Glasgow
12.2011 - 06.2014
- Conducted adverse event management for assigned projects
Safety Specialist II
INC Research (formerly Kendle)
Glasgow
07.2009 - 12.2011
- Conducted adverse event management for assigned projects
Senior Safety Specialist
Kendle International Inc. (formerly Charles River)
Glasgow
07.2006 - 07.2009
- Conducted adverse event management for assigned projects
Pharmacovigilance Scientist II
Charles River (formerly Inveresk)
Glasgow
10.2002 - 07.2006
- Conducted adverse event management for assigned projects
Product Safety Scientist II
Inveresk (formerly Clintrials)
Glasgow
10.2001 - 10.2002
- Conducted adverse event management for assigned projects
Product Safety Scientist I
Clintrials
Glasgow
07.2000 - 10.2001
- Conducted adverse event management for assigned projects
Drug Safety Assistant
Parke-Davis & Co
Eastleigh
07.1999 - 03.2000
- Conducted adverse event management for assigned projects
Education
Bachelor - Microbiology (Medical)
University of Surrey
Guildford01-1999
Skills
- Drug safety reporting
- Adverse event case processing
- Pharmacovigilance delivery
- Safety database management
- Regulatory compliance
- Regulatory requirements understanding
- Quality control procedures
- Inspection readiness and oversight
- Continual process improvement
- Budgeting and financial analysis
- Multi-tasking and time management
- Excellent time management skills
- Onboarding processes and procedures
- Administrative procedures
LANGUAGES
English
Certification
01-MAY-2004, Eudravigilance Accreditation
PUBLICATIONS & PRESENTATIONS
- DATE PUBLISHED /PRESENTED
- 01-JUN-2007
- Electronic End-Point Adjudication Justifies The Means, Good Clinical Practice Journal.
THERAPEUTIC EXPERIENCE
- Pain
- Ischemic heart disease
- Chronic heart failure (CHF)
- Burns
- Diabetes, type 1
- Diabetes, type 2
- Hemophilia B
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
- Infectious Diseases including HIV
- Huntington's disease
- Stroke
- Leukemia
- Non-Hodgkin lymphoma (NHL)
- Bladder cancer
- Glioblastoma multiforme
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Ovarian cancer
- Macular edema
- Retinal vein occlusion
- Age-Related Macular Degeneration
- Smoking cessation
- Chronic obstructive airways disease
- Asthma
- Surgical procedures
- Urology
- Benign Prostatic Hyperplasia
STUDY DESIGN EXPERIENCE
- Double Blind
- Long-term extension (LTE)
- Open Label
Hobbies and interests
- Playing darts and pool
- Animal-lover, proud cat-mum of 2
- Watching true crime documentaries and YouTube videos
- Listening to music, particularly dance/house, r&b, disco.
- Have travelled to Australia, New Zealand, Europe, USA
Timeline
Associate Director, Safety & Pharmacovigilance
Syneos Health
05.2022 - Current
Safety & PV Project Delivery Manager
Syneos Health
12.2020 - 04.2022
Safety & Pharmacovigilance Program Delivery Lead
Syneos Health
06.2019 - 11.2020
Senior Safety Specialist
Syneos Health
04.2018 - 06.2019
Safety Specialist II
Syneos Health
06.2016 - 03.2018
Senior Safety Specialist
INC Research
12.2011 - 06.2014
Safety Specialist II
INC Research (formerly Kendle)
07.2009 - 12.2011
Senior Safety Specialist
Kendle International Inc. (formerly Charles River)
07.2006 - 07.2009
Pharmacovigilance Scientist II
Charles River (formerly Inveresk)
10.2002 - 07.2006
Product Safety Scientist II
Inveresk (formerly Clintrials)
10.2001 - 10.2002
Product Safety Scientist I
Clintrials
07.2000 - 10.2001
Drug Safety Assistant
Parke-Davis & Co
07.1999 - 03.2000
Bachelor - Microbiology (Medical)
University of Surrey