Gil Roth08.19.13
Stephen W. Sun, M.D., M.PH. has been named chief medical officer at ParagonRx, an inVentiv Health company. He will advise clients on regulatory and safety issues and will report directly to ParagonRx president Jeffrey Fetterman.
"The focus today is on enhanced pharmacovigilance, putting preventions in place before any regulatory body requires it," said Mr. Fetterman. "Dr. Sun's FDA experience will enrich the guidance we offer clients to assure that active risk management is at the core of developing all new products and services."
Dr. Sun has worked at Organon in Drug Safety and Medical Knowledge Management, at Alpharma as director of Drug Safety and senior director of Medical Affairs, at King Pharmaceuticals as senior director of Pharmacovigilance and Risk Management, and at Reckitt-Benckiser, where he was involved in over-the-counter medications. Dr. Sun later joined the FDA as a medical officer and served in the CDER Division of Risk Management and most recently in the Controlled Substances Staff. Highlights of his tenure at the FDA include the TIRF class REMS, the proposed standardization of abuse-related adverse event MedDRA terms and the development of a surveillance system using mobile technology.
"The focus today is on enhanced pharmacovigilance, putting preventions in place before any regulatory body requires it," said Mr. Fetterman. "Dr. Sun's FDA experience will enrich the guidance we offer clients to assure that active risk management is at the core of developing all new products and services."
Dr. Sun has worked at Organon in Drug Safety and Medical Knowledge Management, at Alpharma as director of Drug Safety and senior director of Medical Affairs, at King Pharmaceuticals as senior director of Pharmacovigilance and Risk Management, and at Reckitt-Benckiser, where he was involved in over-the-counter medications. Dr. Sun later joined the FDA as a medical officer and served in the CDER Division of Risk Management and most recently in the Controlled Substances Staff. Highlights of his tenure at the FDA include the TIRF class REMS, the proposed standardization of abuse-related adverse event MedDRA terms and the development of a surveillance system using mobile technology.