Associate Director, Drug Safety

Associate Director, Drug Safety

For our rapidly growing facility in Rockville, Maryland, we are seeking a bright, professional, personable, and dependable addition to our team.

Associate Director, Drug Safety

Your major tasks will be:

• Supervision of compliance with reporting obligations resulting from AMG § 63b Abs. 1-4, 7 and 8 and GCP regulation § 13 Abs. 1-3 for Germany and applicable international regulatory guidelines
• Contribution to SOPs covering the pharmacovigilance system
• Preparation of and/or contribution to safety parts in dossiers (eCTD, Annual Safety Report, Clinical Study reports, IB, IMPD)
• Contribution to the preparation of Safety Plans and Working Procedures concerning internal and external workflows
• Evaluation of all serious adverse events as to seriousness, expectedness and causality
• Coordination of data flow and processing of serious adverse events
• Analysis of safety data, benefit-risk assessment
• Decision making in processes related to the collection, evaluation and reporting of adverse events in Micromet sponsored studies

Your profile:

• Medical background, high interest in legislation and update knowledge in all applicable guidelines
• 2-3 years professional experience
• Excellent command in German and English, MS Office
• Excellent communication skills, integrative thinking, assertive, results oriented

The offer:

• The successful candidate will have the unique opportunity to work for and gain experience in an international company with a dynamic and collegial environment
• The successful candidate will be given interesting tasks with opportunities for personal initiative and professional growth
• The compensation and benefits will be market competitive and commensurate with experience

We look forward to receiving your application.

Micromet is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTE® technology, as well as conventional monoclonal antibodies. Three of Micromet's BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Sanofi-Aventis, Bayer Schering Pharma, Merck Serono, Boehringer Ingelheim, MedImmune, Nycomed and Amgen. Micromet's corporate headquarters are located in Rockville, Maryland, and its Research and Development facility is located in Munich, Germany.