| Primary Responsibilities:
OSI Pharmaceuticals Inc. currently has an opening for a Director/Sr. Director in our Drug Safety Department. The Sr. Director, Drug Safety will be responsible for all product safety activities for OSI’s marketed and investigational agents for all therapeutic areas both domestically and internationally. The incumbent’s primary role is to oversee all medical aspects of the drug safety activities within the unit and as the most senior person, this individual will work closely with the Director of Safety Operations on single-case processing, triaging, evaluation and reporting. In collaboration with the unit’s other Safety Physicians, the candidate is expected to provide medical assessment of incoming adverse event information for OSI products. This includes but is not limited to assessment of possible causality, seriousness, labeledness/expectedness, and regulatory reportability. The person will also ensure review of adverse event coding for individual safety cases and aggregate information from clinical trials, ongoing evaluation of potential new safety signals for OSI products and working proactively to ensure proper communication of relevant findings. Additional responsibilities include assessing developing safety information, anticipating potential impact on product labels, communicating implications and developing strategies for clinical and regulatory issues. The selected individual will collaborate with other OSI colleagues to address safety findings from clinical trials and postmarketing information and make recommendations for labeling changes. This position will be responsible for writing safety sections for completed trials, drug applications, and periodic reports. Finally, the person will line-manage personnel within the group and will mentor and promote congeniality and teamwork among peers.
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