Principal CMG Liaison Scientist
- Brentford, Greater London (GBR)
- £28 - £32 Per Hour
- 3 Months
- Start date: ASAP
- Ref: CMGLIAS
- clinical safety
- compliance
- capa
- data collection
- sops
- documentation
- case management
- coordinates
- licensing
- life cycle
- reporting
- risk management
- implementation
- strategy
Job description
Posted 12 February 2021
Principal CMG Liaison Scientist
Role is working fully remote
Core Liaison Accountabilities
- Contributes and interacts with stakeholders (i.e. 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 Global 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
Principal Liaison Accountabilities
- Supports Scientists with enhancement of knowledge and skills with regards to Liaison activities, where required
- Identifies training needs; prepares, coordinates and delivers training to staff within CMG and departments outside of SMG; designs, produces and maintains the CMG core curricula
- 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
Essential Core Liaison 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
- 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 (e.g. pharmacist or nurse) preferred.
· In-depth knowledge of GSK safety database strongly preferred
· Knowledge of GSK products
