Clinical Scientist: Respiratory, Pharmacovigilance
£40,000 - £45,000
The key purpose of this role is to ensure the safety of all Clinical Trial participants and patients administered with the client's products, by ensuring the successful collection, assessment and reporting of safety data (adverse events).
This role ensures that case processing activities align with corporate 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.
· 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 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
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 summarising 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 Candidates with a background as a Health care professional preferred although not essential
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