CMG Scientist

Global CMG Alliance Scientist

Department:

Safety and Medical Governance (SMG)

Description:

·      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 managing case processing activities and overseeing the case processing vendor.

·      The job holder ensures relevant Alliance-related oversight to the Case Management Group (CMG) Directors and drives the understanding of adverse event collection requirements across all business units

ACCOUNTIBILIITES / RESPONSIBILITIES:

Core Alliance 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; where problems or issues are identified, facilitates investigation into root cause and creation of corrective/preventative actions (CAPAs)

·      Communicates and works collaboratively with CMG Quality and Compliance to enhance quality of case processing activities

·      Acts as a point of contact for the vendor, for audits and inspections and contributes to CAPAs specific to case management activities

·      Contributes to all aspects of case handling activities from case receipt to expedited reporting and interactions with the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs), and clinical operations

·      Generates new ideas and proposals for global implementation; contributes to advancement of CMG methodology and processes

·      Ensures third parties/vendors develop and implement robust processes to support quality-driven organization

·      Reviews and maintains oversight of training materials developed by third parties/vendors

·      Accountable to build external relationships with key stakeholders to ensure successful delivery of outsourced work, demonstrating GSK values during interactions

·      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

·      Recommends system enhancements to improve case processing compliance and quality; supports innovation from idea to implementation.

Essential Core Alliance 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 Alliance skills and experience

·      Health care professional (e.g. pharmacist or nurse) preferred

·      In-depth knowledge of safety database strongly preferred

·      Knowledge of GSK products

·      Project management experience

·      Vendor management experience

Core Alliance Competencies

·      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, i.e. ORACLE)

·      Demonstrates project management skills in a global matrix environment

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