Clinical Scientist: Respiratory, Pharmacovigilance
Role is working from home
Must be immediately available – 1 week notice Max
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 liaising with global stakeholders (both internal and external).
The job holder ensures relevant liaison-related oversight to the Case Management Group (CMG) Directors and drives the understanding of adverse event collection requirements across all business units.
Core Liaison Accountabilities
Contributes and interacts with stakeholders (ie the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), MAPs and clinical operations) to ensure that all documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and a product (following approval).
Liaises with other CMG divisions (Quality & Compliance and Alliance) to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and a product (following approval).
Contributes to CAPA development
Works across a complex Matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements
Manages Liaison mailboxes for Spontaneous and Clinical Trial queries and responds to allocated queries in a timely manner
Where problems or issues are identified, escalates to CMG Liaison Manager
Generates new ideas and proposals for global implementation; contributes to advancement of CMG methodology and processes
Builds external relationships with key stakeholders
Demonstrates GSK values during interactions
Skills and Experience
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
Project management experience preferred
In-depth understanding of medical and drug terminology
Proven experience of Prioritisation and time management
Strong communication skills
Desirable Liaison skills and Experience
Health care professional (eg pharmacist or nurse) preferred.
In-depth knowledge of GSK safety database strongly preferred
knowledge of GSK products
Demonstrates GSK values in behaviour and attitude to all activities
Demonstrates technical expertise in clinical trial safety processes, including regulatory interpretation, SOPs/guidances, and systems/database conventions
Possesses comprehensive operational knowledge and understanding of the drug development process and drug approval process in major countries
Able to prepare and effectively present data/information within and outside of the Central Safety Department (CSD)
Demonstrates excellent oral and written communication skills
Attention to detail, but demonstrates pragmatism where appropriate or high degree of accuracy and attention to detail
Possesses solid/excellent technical writing skills
Possesses solid/excellent computer skills and computer literacy (e-mail, word processing, PowerPoint, prefer experience with relational databases, ie Oracle)
Demonstrates project management skills in a global Matrix environment
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