Pharmacovigilance Quality & Compliance Coordinator
12 Month initial Contract
Pay rate up to £375 per day via Umbrella inside IR35
Remote working with quarterly visits to Brentford
The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants and patients administered GSK products, by ensuring the successful collection, assessment and reporting of safety data (adverse events).
This role ensures that case processing activities align with GSK standards for processing HSI and that regulatory timelines are achieved. This is done by ensuring Quality of CMG data and Compliance with Regulatory Requirements and company procedures.
The job holder ensures relevant Quality and Compliance-related oversight to the Case Management Group (CMG) Directors and drives the Quality and Compliance processes.
ACCOUNTIBILIITES / RESPONSIBILITIES:
(deliverables, scope, complexity, impact on strategy, policy, people relationships)
Core Quality Accountabilities
· Works across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements
· Generates new ideas and proposals for global implementation; contributes to advancement of CMG methodology and processes
· Monitors Key Performance Indicators (KPIs) ensuring compliance and quality thresholds are met and any metrics indicating missed KPIs are addressed.
· Input into Root Cause Analysis (RCA) and corrective/preventive action (CAPA) formation/effectiveness checks
· Independent quality review of cases processed by vendor
· Ensures appropriate reporting activities are complete, as per Regulatory requirements
· Ensures that changes to Regulations are assessed for impact and any necessary changes are implemented, also providing awareness to QPPV Office.
· Support risk assessment and management of risk registers
· Supports Inspections/Audits (led by PVQA of Central/LOC/Vendor processes)/ LP Audits/ Regulatory Inspections (Central and LOC)/ Notified Body Audits
· Ensures appropriate management monitoring activities are complete
· Where problems or issues are identified, ensures appropriate escalation and resolution
· Demonstrates GSK values during interactions
Principal Quality and Compliance Accountabilities
· Supports Scientists with enhancement of knowledge and skills with regards to Quality and Compliance activities, where required
· Identifies training needs; prepares, coordinates and delivers training to staff within CMG and departments outside of CMG;
· Act as a global Case Management leader for process discussions, including queries on strategy/policy related decisions; authors or provides significant input to standard operating procedures (SOPs) and guidance documents
· Drives implementation of new regulations and maintenance of EMA/CRO/licensing partner reporting rules; demonstrates expert working knowledge of the regulatory environment on a global level
SKILLS AND EXPERIENCE
Essential Core Quality and Compliance skills
· Degree in life sciences or medically related field or previous experience equating to educational requirements.
· Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements
· Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
· PV Quality and Compliance experience preferred
· In-depth understanding of medical and drug terminology
· Proven experience of Prioritisation and time management
· Strong communication skills
Desirable Quality and Compliance skills and Experience
· Health care professional (e.g. pharmacist or nurse) preferred.
· In-depth knowledge of GSK safety database preferred
· Knowledge of GSK products
Global CMG Quality and Compliance Principal Scientist
· Proven experience developing and delivering high-quality training
· Experience of providing mentoring to other staff