Description:
We are looking for Associate Director, Pharmacovigilance Operations – ICSR Management to join our team.
You will be responsible for vendor oversight of case processing and related activities, ensuring adherence and compliance to GSK processes and contracted tasks. You will oversee/contribute to investigations into non-compliance, perform gap analysis, critically analyse data and metrics produced by the vendor. You will manage the GSK ICSR Management team and ensure all ICSR management activities are appropriately resourced and escalate any resourcing issues. You will provide strategic advice to the function, generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
In this role you will
- Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders (i.e., the Safety Evaluation and Risk Management (SERM) group, local operating companies (LOCs) and clinical operations/sciences) 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.
- Work 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, facilitate investigation into root cause and create corrective/preventative actions (CAPAs)
- Escalate identified problems or issues to the appropriate Management Personnel with PV Operations
- Ensures third parties/vendors develop and implement robust processes to support quality-driven organization.
- Supervise the team of scientific staff responsible for supporting ICSR Management activities. Ensure that all ICSR Management activities are appropriately resourced and escalates any resourcing issues
- Provides project management and case processing oversight for clinical trials and post-marketed programs, support spontaneous case processing activities; ensure timely completion of deliverables
Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Degree in life sciences or medically related field or previous experience equating to educational requirements.
- Case processing experience in clinical trials and post-marketing.
- Experience in quality processes for PV including compilation of compliance metrics, writing deviations / quality issue reports
- Experience in performing trend analysis, gap analysis. SOP writing experience.
- Knowledge and experience with pharmacovigilance systems