Educated, accomplished and analytical MD with a special interest in drug safety surveillance. Post doctoral graduate fellowship training at Tufts Medical School and Oakridge Fellow at CBER, FDA. Vast experience in managing patients with kidney disease. Able to organize, coordinate and effectively conduct clinical research. Avid proponent of continuous process improvement, optimal patient care, and research and development. Strong leadership skills aimed at providing clinical excellence in: • Clinical Research • Drug Safety Surveillance Signal Detection Career enhancement in pharmaceutical industry.

VICE PRESIDENT, DRUG & DEVICE SAFETY OFFICER @ Responsible for overseeing the compliance of all FMC/RTG LLC manufactured products (drugs and devices) to Health Regulators towards detection, investigation, and reporting of adverse events with proactive signal detection to ensure benefits exceed the risk Hired to mentor, guide, and provide oversight to the Director of Pharmacovigilance towards building a premier PV functional unit within Fresenius RTG Quality Systems Responsible for driving the FMCNA culture through values and customer service standards by providing outstanding service to all internal and external stake holders, throughout product life-cycle Maintain effective relationships for timely communication concerning all FMC/RTG LLC manufactured product complaints. Responsible for safety surveillance activities concerning device and drugs Provide medical oversight of critical events safety issues through application of accurate medical judgment to support decisions towards adherence of compliance. Provide medical guidance and mentor staff and applicable departments within FMCNA to help prepare and maintain SOPs within the department Provide input on required IT and software requirements to support PV function Train staff and complaint team, as needed, towards supporting the medical department concerning CAPA, PAR, HHA for evaluation of Harm List and evaluation of Risk Assessment Collaborate with the Risk Management Team and Complaint Manager to ensure complaint severity levels are well managed through active participation in PSO meetings. From May 2015 to Present (8 months) Medical Director, Global Patient Safety @ Hired to govern and guide programs, clinical teams and departmental activities as they relate to safety. Conduct reviews of safety reports from clinical trials or post-markting sources as well as evaluation of safety-related information from toxicology, non-clinical studies and product quality complaints. • Play a key role in protocol development of safety information in clinical trial protocols and statistical analysis. Review safety data from current and completed clinical trials and add to Clinical Study Reports. Contribute to the preparation and review of periodic reports (IND, Annual Safety and PSUR). • Guide staff in collection, evaluation and processing of adverse experience reports. • Maintain primary responsibility for the disease-area safety teams for assigned products in developmental phase for early identification of risks and prepare risk mitigation plans through d-RMP in collaboration with epidemiology team. Chair DST meetings with relevant stake holders to ensure benefits of the drugs during development phase exceeds the risk for patient protection. • Review and provide medical content, as needed for key study-related documents' e'g' IB' ICF and IDMC charter • Participate in SOP and work instruction development to identify gaps to improvise work processes. • Key player in Partner/Affiliate agreements and interaction. From April 2011 to Present (4 years 9 months) Associate Medical Director, Drug Safety Office @ From January 2009 to December 2010 (2 years) Associate Medical Director @ From 2004 to 2010 (6 years) Associate Medical Director, Schering-Plough Research Institute @ From 2004 to 2009 (5 years) Senior Medical Officer; Division of Nephrology, Departmen of Internal Medicine @ From April 1982 to June 1999 (17 years 3 months) Medical Officer, Department of Nephrology @ From September 1976 to March 1982 (5 years 7 months) Medical Officer, Department of Internal Medicine @ From September 1974 to August 1976 (2 years)

Oakridge Fellow at CBER, FDA, Drug Safety, Signal Detection and Risk Management @ Oakridge Associated University, TN From 2002 to 2003 MS, Clinical Care Research, Epidemiology and Health Care Outcomes @ Tufts University School of Medicine From 1999 to 2003 MS, National Health Policy @ The Heller School for Social Policy and Management at Brandeis University From 1999 to 2000 MB;BS, Medicine & Surgery @ Dhaka Medical College, Bangladesh From 1973 to 1973 MBBS, Medicine & Surgery @ Dow Medical College From 1967 to 1972 MB;BS, Anatomy/Physiology/Pharmacology/Pathology/Forensic Medicine/Community and Public Health @ Dow Medical College,Karachi Pakistan From 1967 to 1972 F.Sc, Pre-Medical Sciences @ Gordon College, Rawalpindi, Pakistan From 1965 to 1966 I.Sc, Pre-Medical Sciences @ Notre Dame College, Dhaka, Bangladesh From 1964 to 1965 Secondary School Certificate @ Central Government High School From 1960 to 1964 Saint Joseph's High School From 1957 to 1959 Karachi Grammar School; Pakistan From 1956 to 1957 Holy Cross School, Dhaka, Bangladesh From 1952 to 1955 MBBS, Medicine & Surgery @ Dhaka Medical College Tauqeer Karim is skilled in: Clinical Development, Pharmacovigilance, Pharmaceutical Industry, Internal Medicine, Medical Affairs, Clinical Research, Epidemiology, Drug Safety, Evidence-based Medicine, Outcomes Research, Hypertension, Clinical Trials, GCP, FDA, Medical Writing