Medical Safety
Resume:
PATRICK P. MONTEFUSCO, MD
East Brunswick, NJ 08816
Email: ***********@***.***
MEDICAL DOCTOR … ANESTHESIOLOGIST … SURGEON
Cardiovascular Therapeutic Group/Expert Medical Case Evaluator
Bayer HealthCare Pharmaceuticals, Inc Global Pharmacovigilance, Apr-2017 - Present
Receives, reviews, assesses, finalizes and distributes drug safety information on assigned investigational and marketed drugs from U.S. and global sources, ensuring highest quality, accuracy and timeliness with respect to global regulatory guidelines.
Assess adverse drug events with respect to seriousness, relationship to drug product, and global labeling status (expected or unexpected) in order to assign appropriate case reporting status.
Consults in the training and development of Drug Safety personnel.
Global Safety Leader /Oncology Therapeutic Group
Bayer HealthCare Pharmaceuticals, Inc Jul-2015 to Apr-2017
The Global Safety Leader MD provides medical safety expertise, state of the art
pharmacovigilance, and safety risk management for the oncology portfolio of products (both
marketed and in development):
Ensures patient safety and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of GPV assessment activities through product development, product maintenance and life cycle management.
Monitor the benefit risk profile of assigned portfolio in an ongoing fashion:
Chairing Safety Management Teams
Identify, prioritize and analyze clinical safety signals, perform ongoing review of emerging safety data from various sources
Ensure effective and timely delivery of aggregate reports.
Answers to assigned safety relevant Health Authority requests, Safety relevant communications such as DHCP letters and company statements.
Oncology Therapeutic Group/Expert Medical Case Evaluator
Bayer HealthCare Pharmaceuticals, Inc Global Pharmacovigilance, Oct-2007 to Jul-2015
Receives, reviews, assesses, finalizes and distributes drug safety information on assigned investigational and marketed drugs from U.S. and global sources, ensuring highest quality, accuracy and timeliness with respect to global regulatory guidelines.
Assess adverse drug events with respect to seriousness, relationship to drug product, and global labeling status (expected or unexpected) in order to assign appropriate case reporting status.
Consults in the training and development of Drug Safety personnel.
Assistant Surgeon, Raritan Bay Medical Center, Jul-99 to Oct-2007
Practicing Anesthesiologist, Liberty Anesthesia, 1991-1999
Practicing General Surgeon, Brockie Surgical Associates, 1987-88
General Surgical Attending Physician, North Shore University Hospital, 1983-87
Contributed as an Instructor in Clinical Surgery. Authored nine papers on different topics in surgery published in surgical journals. Practiced General Surgery. Trained, taught and supervised Residents in General Surgery. Lectured on surgical topics. Made presentations at surgical meetings. Recruited new Surgical Residents. Conducted selection interviews and evaluated candidates. Instructor in Advanced Trauma and Life Support courses sponsored by the American College of Surgeons.
EDUCATION
Seton Hall Preparatory School - South Orange, NJ 1969
Georgetown University - Bachelor of Science - Biology - Washington, D.C. - 1973
POSTGRADUATE EDUCATION
MD, Georgetown University School of Medicine, 1977
North Shore University Hospital, Manhasset, NY
Medical Internship, 1977-78
Residency in Surgery, 1978-83
UMDNJ - Robert Wood Johnson Medical School, Residency in Anesthesia, New Brunswick, NJ 1988-90
RECENT APPOINTMENTS
Cardiovascular Therapeutic Group/Expert Medical Case Evaluator
Bayer HealthCare Pharmaceuticals Apr-2017 - Present
Global Safety Leader/Oncology Therapeutic Group
Bayer HealthCare Pharmaceuticals Jul-2015 to Present.
Oncology Therapeutic Group/Expert Medical Case Evaluator
Bayer HealthCare Pharmaceuticals Oct-2007 to Jul-2015
POST APPOINTMENTS
Assistant Surgeon, Raritan Bay Medical Center, Jul-1999 to Oct-2007
Attending Anesthesia, CentraState Medical Center, Freehold, NJ, Jan-
1991-99
Attending Surgery, York Hospital, York, PA, 1987-88
Attending Surgery, North Shore University Hospital, Manhasset, NY, 1983-87
POST ACADEMIC APPOINTMENTS
Cornell University, Medical College, Instructor, Clinical Surgery, New York,
NY, 1984-87
PROFESSIONAL SOCIETY MEMBERSHIPS
Diplomate American Board of Anesthesia (1992)
Diplomate American Board of Surgery (1984)
Alpha Omega Alpha
Fellow American College of Surgeons
Phi Beta Kappa
Current New Jersey Medical License
BIBLIOGRAPHY
Geiss, AC.; Speir, N.; Montefusco, PP.: Another Facet of Mirizzi’s Syndrome.
Arch Surg., Oct. 1983
Montefusco, PP.; Geiss, AC.; Bronzo, R.; Randall, S.; M.; Kahn, E.; A
Syndrome Complex: Sclerosing Cholangitis, Chronic Pancreatitis and
Sjogren’s Syndrome. Amer J. Surg, June 822-826, 1984
Montefusco, PP.; Geiss, AC.; Randall, S.; Typhoid Fever and Massive
Intestinal Hemorrhage, Con Surg, March 24: 61-64
Geiss, AC.; Montefusco, PP.; Technique for the Placement of an Implantable
Percutaneious Permanent Triple Lumen Catheter. AM J Surg, 149: 395-396,
1985
Montefusco, PP.; Ward, RJ.; Geiss, AC.: Recurrent Adhesive Small Bowel
Obstruction, Con Surg, Oct 98-100, 1985
Keckeisen, G.; Montefusco, PP.; Ward, RJ.; Geiss, AC.: Myonecrosis of the
Abdominal Wall, Inf in Surg 5:626-628, 1986
Schwartz, A.; Montefusco, PP.; Ward, RJ.; Greenspan, J.; Geiss, AC:
Salmonella Splenic Abscess. Inf in Surg, June 1986
Montefusco, PP.; Geiss, AC.: Accessory Splenectomy in Management of
Idiopathic Thrombocytopenia Purpura. Con Surg, January 1988
Montefusco, PP.; Pogo, G.; Bronzo, RL; Kahn, E.; Geiss, AC.; Mesenteric
Panniculitis A Cause of Double-barreled Intussusception of the Small
Intestine. Con Surg, 31(3): 22-26, 1988
Scientific Exhibits:
Anatomy of the Lower GI Tract: Presented at the Flexible Fiberoptic
Sigmoidoscopy Symposium, North Shore University Hospital, Manhasset, New
York, March 10, 1983
Typhoid Fever and Massive Intestinal Hemorrhage: Presented at the American
College of Surgeons Clinical Congress, Atlanta, Georgia, October 1983
Superior personality qualities include integrity, concentration, focus on results, caring, painstaking attention to detail, persistence in the face of adversity, dedication to patient interests, willingness to devote adequate time to assure optimum results, total professionalism, and many more.
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