Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials.
Manages case management activities for assigned clinical studies to ensure compliance with national and international regulations, such as GxP guidelines and/or other relevant international and national legislation, regulations, guidance, and company policies and procedures within the area of responsibility.
Manages the delivery of the Safety Reporting Plans, ; identifies, implements, and monitors KPIs/KQIs across clinical case management activities;
Supports the preparation and conduct of PV and other GxP inspections and audits, as required, .
Establishes, maintains, and/or ensures maintenance of clinical trial case management required documents, such as safety reporting plans and reporting responsibilities , in line with international and national regulations, guidelines, and internal standards.
Oversee the Vendors to ensure GSPV standards are maintained with respect to processing of SAE, AESI and pregnancy clinical trial cases and compliance with respect to expedited reporting in clinical trials.
Act as primary contact for external vendors for all GSPV PV Operations clinical trial queries pertaining to their assigned Clinical trials.
Prepare & Provide Study specific training to external vendors and GSPV team members involved in the given clinical trial.
Participate in any drug safety database enhancements and upgrades by providing input from a clinical trial perspective.
Develops, implements, and oversees pharmacovigilance procedures and processes and ensures the uniform and timely processing and analysis of safety data to comply with regulatory requirements.
Ensures correct coding of all event and drug terms.
Ensures inter- and intra-consistency for case evaluations.
Leads or oversees ICSR reporting compliance analyses provided by vendors and associated CAPAs from clinical trial case management.
Acts as a liaison internally and with external collaborators to develop processes that meet regulatory reporting requirements.
Oversees preparation of Suspected Unexpected Serious Adverse Reactions for submission to external regulatory agencies.
May lead or contribute to cross-functional projects to fulfill GxP requirements and improve inspection readiness.
Bachelor's degree or equivalent in a life science discipline (e.g., nursing, biological sciences, pharmaceutical sciences, or Medical Documentation). Master's or PhD in Life Sciences preferred.
7+ years of Pharmacovigilance experience in a multinational pharmaceutical industry environment.
Expert knowledge of local and international regulations and PV processes.
Knowledge of local and international GxP regulations, IT standards, and other relevant legislation, including privacy protection requirements.
Experience with regulatory inspections.
Experience administering complex data sets.
Experience managing CAPA and SOP development projects.
Experience with relevant software applications.
Experience working within a GxP-regulated environment.