- The key purpose of this role is to ensure the safety of all Clinical Trial participants, patients, and consumers administered or using products, by supporting the successful collection, processing and reporting of safety data (adverse events) of products globally. This role ensures that case management activities align with 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 case processing activities and overseeing the PV case processing vendors. The job holder provides relevant ICSR Management-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 ICSR Management Accountabilities
• 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)
• Communicates and works collaboratively with case management Quality and Compliance to enhance quality of case processing activities
• Acts as a point of contact for the vendor
• 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 and keeps case management Excellence informed of any changes.
• 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 ICSR Management mailboxes for Spontaneous and Clinical Trial queries and responds to allocated queries in a timely manner
• Where problems or issues are identified, escalates to ICSR Manager
• Generates new ideas and proposals for global implementation; contributes to advancement of case management methodology and processes.
• Demonstrates values during interactions
SKILLS AND EXPERIENCE
Essential Core skills:
• Degree in life sciences or medically related field or previous experience equating to educational requirements.
• Knowledge of 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
• In-depth understanding of medical and drug terminology
• Proven experience of Prioritization and time management
• Strong communication skills
• In-depth knowledge of safety databases strongly preferred
Desirable skills and Experience:
• Knowledge of products
• Project management experience
• Vendor management experience
• Knowledge and experience with safety systems
Core ICSR Management Competencies
• Demonstrates values in behavior and attitude to all activities
• Demonstrates technical expertise in clinical trial safety processes, including regulatory interpretation, SOPs/guidance’s, 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
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
your application has been submitted