Clinical Safety Scientist – PV Operations
£289.82p/d Max via Umbrella
The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants, patients, and consumers administered or using GSK products, by supporting the successful set up of studies/programs, collection, processing and reporting of safety data (adverse events) of GSK products globally.
This role ensures that case management activities align with GSK standards for processing human safety information (HSI) and that regulatory requirements, including timelines are achieved. This is done by liaising with global stakeholders (both internal and external), managing study set up and case management activities.
This position holder will play a key visible role to ensure that GSK regulatory and reputational risk is minimized
· Assist with the set-up studies including the review of study documents such as protocols, contracts, Clinical Trial Applications etc.), safety slides, AE/SAE forms, Kick off Meetings attendance
· Review of Safety Management Plans (SMP), Data Management Plans (DMP), Protocol Data Entry Guidelines (PDEGs) and completion of start-up/close out checklists
· Prepares and submits safety database configuration requests, reviews UAT outputs for Electronic Data Capture (EDC) and SDB, assists the study lead in vendor training
· Assist Study Leads in conducting spot checks in JIRA to ensure relevant documents have been filled appropriately.
· Assist Study Leads with the oversight of study reconciliation activities
· Escalations to the study lead, as needed
· Contributes to all aspects of case handling activities from case receipt to expedited reporting and collaborates with stakeholders (i.e. the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) and clinical operations) to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product.
· Works across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements; where problems or issues are identified, facilitates investigation into root cause and creation of corrective/preventative actions (CAPAs)
· Reviews and maintains oversight of training materials developed by third parties/vendors
· Monitors key performance indicators (KPIs) generated from supplier and quality organizations, determines appropriate responses to manage and mitigate risk, and identifies issues for escalation/action as required.
· Maintains awareness of EMA/CRO/licensing partner reporting rules and ensures case handling is performed in alignment with reporting timelines and expectations; demonstrates expert working knowledge of the regulatory environment on a global level
· Manages PV Operations mailboxes for Spontaneous and Clinical Trial queries and responds to allocated queries in a timely manner
· Where problems or issues are identified, escalates to PV Operations Manager
· Generates new ideas and proposals for global implementation; contributes to advancement of PV Operations methodology and processes.
· Demonstrates GSK values during interactions
Essential Core 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 Trial Regulations, 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
· In-depth understanding of medical and drug terminology
· Proven experience of prioritisation and time management
· Strong communication skills
· In-depth knowledge of safety databases strongly preferred