Mari Welke is a seasoned independent consultant at Yellow Pelican Writing & Consulting, L.L.C., bringing over 25 years of extensive experience in the pharmaceutical industry. Her expertise spans the entire product lifecycle, from first-in-human (FIH) clinical trials to the complexities of global post-loss-of-exclusivity stages. Mari's...
Mari Welke is a seasoned independent consultant at Yellow Pelican Writing & Consulting, L.L.C., bringing over 25 years of extensive experience in the pharmaceutical industry. Her expertise spans the entire product lifecycle, from first-in-human (FIH) clinical trials to the complexities of global post-loss-of-exclusivity stages. Mari's role encompasses a wide array of responsibilities, including pharmacovigilance operations, strategy formulation, and the meticulous preparation of critical regulatory documents such as Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR/PBRER), and Risk Management Plans (RMP).
At Yellow Pelican, Mari is instrumental in enhancing compliance and operational efficiency through her adept skills in process analysis, development, and optimization. She has successfully led initiatives focused on policy and Standard Operating Procedure (SOP) development, ensuring adherence to worldwide regulatory requirements and ICH-GCP guidelines. Her commitment to transparency and inspection readiness is evident in her work on compliance remediation, where she evaluates inspection readiness and resolves Corrective and Preventive Actions (CAPA).
Mari's strategic consulting extends to clinical trial disclosure preparation and process development, where she leverages her deep understanding of clinical trial management systems (CTMS) and drug development processes. Her ability to build and design effective teams further enhances her contributions, allowing her to foster collaboration and innovation in the projects she undertakes. With a robust foundation in safety analysis and medical writing, Mari Welke stands out as a key player in the pharmaceutical landscape, dedicated to driving excellence in pharmacovigilance and clinical trial management.
