Innovative senior pharmacovigilance and risk management leader and expert with 14 years global pharmacovigilance and device-vigilance experience from first-in-human to end of drug-life-cycle. Recognized for the ability to turn around difficult challenges in compliance and department structure, building teams of excellence, creating state-of-the-art pharmacovigilance departments, and innovative risk management approaches to ensure product safety. Demonstrated business leadership and strategic capabilities with senior managerial experience. Key elements in pharmacovigilance device-vigilance excellence include: Data Mining and Signal Detection (large and small databases) Signal Translation (safety analysis and risk evaluation) Medical Evaluation of Safety Information (development of structured algorithms) Risk Communication (internal and external) Risk Management Plan Development, Implementation, Re-Evaluation and Follow-Up (REMS and EU RMP) Licensing Evaluation and Due Diligence Aggregate Analysis and Reporting Pharmacovigilance Agreements EEA QPPV job configuration and compliance Product marketing authorization submission and advisory committee defense (EU and US) Transactional Case Processing (process improvements and compliance) Safety database configuration, implementation and maintenance Implementation of off-shoring strategies for transactional functions Device Vigilance reporting and Medical Device Reporting Complaint trending for devices and drug product quality Device risk assessment and Health Hazard Evaluations Product quality and risk assessments MD, PhD, psychiatrist and clinical pharmacologist with 8 years of academic and practice experience and 16 years of industry professional experience

VP Global Pharmacovigilance and Product Safety @ Lead the Global Safety organization, including case processing, risk management, pharmacovigilance, device-vigilance and all associated quality, training, and compliance activities. Manage all strategic, organizational, and administrative activities required for successful operation of the function across multiple sites and diverse cultures. Drive the definition of Safety strategies; establish operational goals in line with strategies, monitor progress against them, and hold direct reports accountable for their roles in achieving them. Overseeing staff of ~ 120 globally (USA, Canada, Mexico, Brazil, Philippines, China, South Korea, UK, Italy). Reengineered the device Vigilance and Medical Device reporting process from 20-40 late submissions/month to 0 late submissions. Addressed and mitigated all critical health authority observations and from device notified bodies. Implemented and reengineered the device complaint handling process to ensure timely compliant complaint processing in Europe as Single Point of Accountability. Developed and implemented process improvements resulting in departmental cost reduction of 35%. Implemented a comprehensive, transparent, audit robust and companywide safety governance process Implemented in collaboration with respective functions a new device risk assessment process, resolving critical health authority findings. Developed the epoetin biosimilar REMS as Single Point of Accountability. Implemented post marketing sample analysis logistics and process for biosimilar immunogenicity evaluation Identified and implemented cost saving off-shoring opportunities for transactional tasks (case processing) in the Philippines and India for devices and pharma products. From April 2013 to Present (2 years 9 months) VP Safety Surveillance and Risk Management / Global Pharmacovigilance and Epidemiology @ Re-organized the scientific PV functions to achieve greater scientific vigor and gain efficiencies Integrated medical evaluation, signal detection, data mining, and risk management into one seamless state-of-the-art process. Developed and implemented a comprehensive signal management and safety governance process. Overseeing staff of physicians and scientists in Paris France, Bridgewater NJ, and Boston, MA. Signal detection, data mining, and risk management for all Sanofi and Genzyme device and device combination products Developed and implemented an electronic system for the tracking and workflow of all safety information (Safety Information Tracking System). The system ensures compliance with recent new EMA PV legislation for signal tracking and the new PSUR/PBRER format Developed and implemented signal management compliance and performance metrics. Represent the company at Health authority meetings (FDA advisory committee meetings, EMA scientific advisory group, CHMP oral explanations) From March 2011 to April 2013 (2 years 2 months) Corporate Safety Officer & VP Global Pharmacovigilance and Epidemiology @ Appointed to organize and build the Safety Department, perform a major overhaul of processes and procedures and manage MHRA, AFSSAPS and FDA pharmacovigilance inspections to resolution of several critical findings. Restructured and rebuilt the Cephalon pharmacovigilance group and processes, hired key individuals, identified and eliminated multiple company legacy issues related to reporting compliance and resolved several critical findings during pharmacovigilance inspections from both MHRA and AFSSAPS. Conceived (patent pending) and led development of world's first comprehensive electronic REMS system including restricted drug distribution, patient, prescriber and pharmacist education and certification process and respective dispensing stops. Established de-novo pre and post marketing signal detection, including data mining and aggregate ratio analysis resulting in a reliable, thorough, standardized signal detection process with reproducible results and a 50% improved product to human resource ratio. Led the company-wide label re-evaluation to systematically update labels for all Cephalon products resulting in globally compliant and robust labels. Implemented a new Company pharmacovigilance database system. Established first de-novo clinical safety and post marketing medical evaluation group with respective evaluation algorithms and processes. Presented to and successfully negotiated with FDA advisory committees, FDA divisions, FDA office of policy, DEA, EMEA, CHMP, MHRA, AFSSAPS. Overhauled and streamlined all pharmacovigilance agreements to conform to updated regulatory requirements and implemented a process to ensure regular review and update where none existed previously. Established the Office of the Qualified Person (QP) in Europe where none existed previously. Created a harmonized approach to PSUR generation and medical content globally resulting in the resolution of repeated expert report findings, improved PSUR quality and 30% resource savings. From 2007 to 2011 (4 years) Vice President, Benefit Risk Management @ Hired as a Senior Director and subsequently promoted to Vice President to manage a medical safety evaluation group of 20 with a yearly budget of up to $18M. Established credibility as senior point of contact for risk assessment within the Benefit Risk Management (BRM) department as well as to senior management and key customers such as the Compound Development Team/Clinical Team, QA, RA, Marketing, Operating Companies and licensing partners. Implemented the Development Core Safety Information (DCSI) concept throughout the J&J pharmaceutical companies. Developed respective global SOP for updating the DCSI resulting in the first operational global SOP to harmonize company procedures. Developed and implemented a structured algorithm for the determinations of Adverse Drug Reactions to comply with the new FDA Physician Labeling Rule and the new European labeling guidance. Established a comprehensive process for Risk Management Plan development and completion to comply with FDA and EU requirements. Developed and implemented key metrics for qualitative and quantitative assessment of the department's deliverables. This approach was used as a model and implemented throughout BRM. Improved group efficiencies by increasing the deliverable output by 70% and maintaining a constant budget. Created in collaboration with therapeutic area counterparts a comprehensive training curriculum for post marketing medical safety data evaluation for physicians and scientists. Represented post marketing safety to health authorities including FDA EMEA, France, Germany, Sweden, Canada From 2004 to 2007 (3 years) Director, Clinical Development @ Clinical leader for antipsychotic bipolar program From 2003 to 2004 (1 year) Director, Clinical Safety @ Managed the global CNS safety team (group size 15; mostly MDs) and 5 direct reports (MDs), managed the resourcing of CNS safety projects and represented CNS safety on Development Governance Bodies. Developed and implemented key processes and templates for safety communication across several therapeutic franchises where none existed previously. Developed first signal detection algorithm for clinical safety date. Established company’s first matrix structure for safety data evaluation, thereby enabling appropriate stakeholder representation and input. Led multiple successful teams for content and/or process definition and improvements (such as risk management plan, periodic comprehensive safety review, signal detection initiative). Initiated, promoted (secured senior management buy in), brought together and led a team which developed the safety physician curriculum, resulting in a company internal award recognition. Led the safety licensing activities and safety assessment in more than 10 due-diligence evaluations of licensing opportunities with key impact on 3 resulting in renegotiation of the licensing agreement. Chaired the Company Abuse Potential Advisory Council comprised of subject matter experts. Led the clinical safety evaluation on phase III drug development teams. From 2000 to 2003 (3 years) Associate Director, Clinical Pharmacology @ Designed clinical trials for phase I to proof of concept as well as phase I index drug-drug interaction studies for major CYP metabolic pathways, developed Early Clinical Development Plans for all CNS early development products, identified biomarker strategies, led study teams. Awarded project team member of the year. From 1999 to 2000 (1 year) German State Doctorate for Clinical Pharmacology (Privat Dozent fuer Klinische Pharmakologie) @ From 1997 to 1999 (2 years) Fellow @ Clinical Phamacology and Experimental Therapeutics From 1994 to 1996 (2 years) Resident Psychiatry/Neurology @ From 1990 to 1994 (4 years)

PhD, Oncology @ Albert-Ludwigs-University, Freiburg im Breisgau From 1988 to 1991 MD @ Albert-Ludwigs-University, Freiburg im Breisgau From 1984 to 1990 Juergen Schmider is skilled in: GCP, Medical Affairs, Clinical Trials, Drug Development, FDA, Pharmacovigilance, Clinical Development, Risk Management, Sop, HPLC, Regulatory Submissions, Clinical Research, Lifesciences, Quality Assurance, Pharmaceutical Industry