Lausanne, Vaud, Switzerland
Trained pharmacist, PhD in neuropharmacology, Diploma in Pharmaceutical Medicine with over 15 years of experience working in all phases of the product lifecycle, including: preparation and attendance of advisory meetings with Health Authorities (US FDA, EMA, Swissmedic); monitoring the safety profile of assigned products during clinical development and post-marketing experience; management of safety signals; preparation of risk management plans, aggregate safety reports, responses to Health Authorities, new submission and renewal dossiers; update of company's internal procedures and working instructions (impacting on drug safety).
The SERM director: Provides high level scientific expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the post-marketing setting, contributing to the overall benefit-risk assessment; Ensures that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives; Has a proven ability to lead safety evaluation activities, ensures that appropriate safety objectives and risk minimisation strategies are included in product development programs and shows confidence, credibility and influence at all levels of the organisation; Presents the disease area or product area safety strategy at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
Oversaw and monitored the safety profile of assigned products based on a comprehensive evaluation of safety information from internal and external sources, including clinical and post-marketing data. Specific tasks included: Providing input and owning medical content of aggregate safety reports (e.g. PSURs, PADERs, safety Risk Management Plans) Providing input on post-marketing experience for registration/switch/renewal dossiers and ensure support to Health Authority queries Providing expert medical safety input to company core safety information and clinical development programs, including post-authorization safety studies (e.g. preparation of clinical trial protocols and reports, safety monitoring of clinical trials) Being responsible for overall medical evaluation of safety signals for assigned products, and for involvement of cross-functional expertise (preclinical, clinical, regulatory), when relevant. Ensure appropriate review of safety topics at the Safety Review Committee Being responsible for development and timely update of key internal safety documents (e.g. when new significant safety information arises). Ensure data consistency among all safety and other project-related documents.
Started as Safety Scientist in 2008; was promoted to Sr. Safety Scientist and then to Team Manager; Was involved in all project phases and interacted directly with clients in Europe and North America; Areas of interest included cancer therapy, pain management, lipid-modifying agents and various Central Nervous System (CNS) disorders, such as multiple sclerosis, Alzheimer’s disease and schizophrenia Prepared or reviewed dozens of safety documents including Risk Management Plans, PBRERs, DSURs, US PADERs, Responses to Health Authorities, Signal Detection Reports, and post-marketing sections of the Common Technical Document Performed safety assessments supporting product labeling updates; Supported all operational functions within the Safety Department including individual case report processing / assessment and periodic review of the scientific literature; Contributed to the development of departmental SOPs and templates; As Team manager, was responsible for the safety writing team at UBC, which included both scientists and physicians; Was awarded the 2011 ‘Above and Beyond’ UBC award (employee of the year in the Geneva office)
The position entailed both research and teaching (Laboratory of Anatomy). Main research topics: 1) mechanisms of astrocytic dysfunction in Alzheimer’s disease; 2) investigating glial activation in an experimental model of focal ischemia. Main achievements: set up the conditions to perform two-photon imaging in vivo; published a peer-reviewed article; wrote and was awarded as co-investigator an 180,000 CHF research grant on Alzheimer’s disease.