Mathieu Peters Email & Phone Number

Leiden, The Netherlands

Have day to day interactions with and provide guidance to the EMEA affiliate Drug Safety Officers to ensure that the affiliate local Pharmacovigilance (PV) systems, processes and procedures are compliant, efficient and in line with global/regional regulatory requirements and Astellas policies and procedures. Monitor affiliate performance and oversee training of affiliate staff. Ensure audit and inspection readiness of affiliates and ensure that CAPAs are developed and implemented in a timely… Show more Have day to day interactions with and provide guidance to the EMEA affiliate Drug Safety Officers to ensure that the affiliate local Pharmacovigilance (PV) systems, processes and procedures are compliant, efficient and in line with global/regional regulatory requirements and Astellas policies and procedures. Monitor affiliate performance and oversee training of affiliate staff. Ensure audit and inspection readiness of affiliates and ensure that CAPAs are developed and implemented in a timely fashion. Show less

Oss, The Netherlands

PV liaison• As part of a dedicated, international liaison team, ensured alignment in case handling between different case processing centers worldwide.• Acted as primary global subject matter expert (SME) on study case processing and devices; resolved issues raised worldwide and created/ updated guidance documents for processing device and study cases.• Served as local point of contact for resolving ad hoc case handling issues.PV Coordinator• Analyzed, coded and… Show more PV liaison• As part of a dedicated, international liaison team, ensured alignment in case handling between different case processing centers worldwide.• Acted as primary global subject matter expert (SME) on study case processing and devices; resolved issues raised worldwide and created/ updated guidance documents for processing device and study cases.• Served as local point of contact for resolving ad hoc case handling issues.PV Coordinator• Analyzed, coded and processed Individual Case Safety Reports (ICSR) for entire Merck product portfolio. Reports included Adverse Experiences for both investigational and marketed products. Show less

Oss, The Netherlands

PV Trainer• Played a key role in the development of a new global training curriculum for spontaneous case processing.• Successfully trained the PV DMC Netherlands team for transition to new Argus Safety database.• Coached and certified new trainers of the PV DMC Poland team.• Created and reviewed training materials.

Oss, The Netherlands

• Triaged and entered (Serious) Adverse Events in the database. Reports concerned a variety of products, both marketed and investigational. • Served as SME in project for new database selection and integration projects after company mergers.• Served as primary trainer for new staff and coached new employees.• Wrote and reviewed case handling procedures (user manuals, work instructions etc.).• Assessed reports on completeness upon receipt and requested additional information if… Show more • Triaged and entered (Serious) Adverse Events in the database. Reports concerned a variety of products, both marketed and investigational. • Served as SME in project for new database selection and integration projects after company mergers.• Served as primary trainer for new staff and coached new employees.• Wrote and reviewed case handling procedures (user manuals, work instructions etc.).• Assessed reports on completeness upon receipt and requested additional information if necessary. Show less