Ann Strauss

• Provide in-line medical safety review of individual case safety reports (ICSRs) arising from Merck clinical trials and other sources as required, to ensure the accuracy, medical assessment and understanding of the safety profile of Merck products
• Specifically provide medical and causality review of new oncology products in phase 1 and 2 of development to ensure compliance with the FDA IND safety rule

MSD South Africa

• Led the development of worldwide strategies for safety analysis of data from clinical trials and pharmacovigilance; including all aspects of safety monitoring, risk management plans, assessing safety for regulatory submission dossiers and information in worldwide package circulars for the Merck portfolio of products based in Bogota Colombia
• Merck Research Laboratories 351 North Sumneytown Pike, North Wales, PA, 19454-2505

• As the CSRM Physician Lead, I was accountable for a team of Physicians (~10) and support staff (~20) that lead the development of all worldwide strategies for safety analysis and monitoring of data from clinical trials and pharmacovigilance; including all aspects of safety This included both developmental and approved products.
• Merck Research Laboratories

• As the CSRM Physician Lead, I was accountable for a team of Physicians (~10) and support staff (~20) that lead the development of all worldwide strategies for safety analysis and monitoring of data from clinical trials and pharmacovigilance; including all aspects of safety This included both developmental and approved products.
• Merck Research Laboratories

• Oversaw all safety analysis and monitoring of assigned global products which included ADHD and Rare Diseases portfolios. Lead pharmacovigilance activities as a member of drug development project teams and co-lead Safety Review Teams. Lead the development and execution of risk management strategies and authored internal risk tracking documents.
• 725 Chesterbrook Blvd
• PA, USA

• Sep 2008 -Mar 2010 (TAH Central Nervous System and Gastrointestinal (CNS/GI) Products. Responsible for leading and managing a team of medical pharmacovigilance physicians and scientists. Responsible for the safety of all assigned products. Key contributor to the benefit risk assessment of investigational CNS/GI products. Responsible for identifying, analyzing and managing risk for assigned products.
• Sep 2006 -Aug 2008 (Vaccines and Anti-Infectives) Responsible for leading and managing a team of medical pharmacovigilance physicians and scientists. Responsible for the safety of all assigned products. Key contributor to the benefit risk assessment of investigational CNS/GI products. Responsible for identifying, analyzing and managing risk for assigned products.
• Collegeville, PA

• Associate Director, Report Evaluation and Safety Surveillance, Worldwide Product Safety and Epidemiology (2001-2003) Responsible for monitoring the safety profile of assigned marketed products which have included products in areas of respiratory, hypertension, arthritis, CINV and PONV (2001-2006).
• West Point, PA

• Medical Advisor

• Training Associate

• Department of Anesthetics, January,1996-December 1996
• Baragwanath General ICU, July 1995-December 1995
• Depart of ENT. Jan 1995-Jun-1995
• Internship Jan 1994-Dec 1994