Principal Scientist, Quality, Compliance & Training

CH JV Principal Scientist, Quality, Compliance & Training

Contract until December 2021

Up to £39 per hour via umbrella

Remote / Brentford

You will ensure the safety of all patients and GSK Clinical Trial participants administered GSK products, by supporting the successful collection, assessment and reporting of safety data (adverse events).

You will ensure that case processing activities align with GSK standards for processing Consumer Healthcare (CH) Human Safety Information (HSI) and that regulatory timelines are achieved. This is done by ensuring quality of Individual Case Safety Report (ICSR) data and compliance with regulatory requirements and company procedures.

In addition, you will ensure relevant quality and compliance and training-related oversight to the GSK PV Operations Directors and help to drive the Quality and Compliance and Training processes.

• Work across a complex matrix environment to drive high-quality delivery of end-to-end case management activities that comply with internal standards and external regulatory requirements
• Work with vendors to ensure high level of quality is maintained and performance standards are met.
• Drive process documentation; author and/or provide significant input to standard operating procedures (SOPs), working instructions and guidance documents
• Act as a representative for process discussions, including queries on strategy/policy related decisions
• Generate new ideas and proposals for global implementation; contribute to advancement of methodology and processes
• Monitor Key Performance Indicators (KPIs) ensuring compliance and quality thresholds are met and any metrics indicating missed KPIs are addressed
• Ensure appropriate reporting activities are complete, as per regulatory requirements
• Input into Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) formation and effectiveness checks
• Perform independent quality review of ICSRs processed by case processing vendor
• Support assessment and implementation of changes to PV regulations
• Support risk assessment and management of risk registers
• Support inspections/audits of Central Safety/Local Operating Company/Vendor processes, Licensing Partner Audits, Regulatory Inspections and Notified Body Audits
• Ensure appropriate management monitoring activities are complete
• Where problems or issues are identified, ensure appropriate escalation and resolution
• Responsible for the training for processing CH HSI from all sources; Identify training needs; prepare, coordinate and deliver training to impacted groups
• Support team with enhancement of knowledge and skills with regards to quality, compliance and training activities

Basic Qualifications:

• Bachelor’s degree in life sciences or medically related field (or equivalent experience)
• Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, pharmacovigilance methodology and general understanding of worldwide regulatory requirements
• Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
• Pharmacovigilance quality and compliance and/or training experience
• In-depth understanding of medical and drug terminology
• Proven experience of prioritisation and time management
• Demonstrates
• Experience of preparing and presenting data/information within and outside of Safety
• Demonstrates excellent oral and written communication skills across cultural and language boundaries as well as excellent technical writing skills
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• Possesses comprehensive operational knowledge and understanding of the drug development process and drug approval process in major countries
• Attention to detail, but demonstrates pragmatism where appropriate
• Excellent computer skills and computer literacy including experience with relational databases i.e. ORACLE
• Ability to act as a training resource demonstrating good presentation skills
• Displays a senior level of coordination ability

Preferred Qualifications:

• Health care professional (e.g. pharmacist or nurse) preferred.
• In-depth knowledge of ARGUS safety database preferred
• Knowledge of GSK CH products preferred
• Proven experience developing and delivering high-quality training
• Experience of providing mentoring to other staff

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