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Medical Safety

Location:
Old Bridge Township, NJ
Posted:
July 16, 2017

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Resume:

PATRICK P. MONTEFUSCO, MD

** ******* ***

East Brunswick, NJ 08816

732-***-****

Email: ac1bx6@r.postjobfree.com

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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