Associate Director, Safety- Case Management - San Diego
Amylin Pharmaceuticals - San Diego, CA

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<p>The Associate Director, Global Safety (Case Management) will have Primarily responsible for management of the Global Safety Case Management Team, Clinical Trial Safety Operations and CRO management. Provides oversight of individual case safety report (ICSR) activities while ensuring the accuracy of aggregate safety data.<br /><br /><strong>RESPONSIBILITIES:</strong></p><ul><li>Manage Case Management Team and CTSO personnel (direct reports, consultants and interns), including mentoring, training, and creating an environment for individual growth through problem solving, decision-making and self-directed learning. (currently 5 direct reports)</li><li>Provides oversight to the individual case safety report (ICSR) activities, ensue a high compliance record regarding individual adverse event case submission and provide strong support to Amylin safety surveillance activities through Global Safety Team (GST). Works with in tight regulatory time constraints</li><li>Ensure ICSR safety reporting compliance in accordance with local and international reporting regulations, standard operating procedures, and safety processing guidelines</li><li>Manages Clinical Trial Safety Operations as subject matter expert to own and control all case management and CTSO processes.

Will ensure that that all existing case process standards (SOP’s, guidelines and business processes) are consistent with other Amylin processes and regulations. Identifies process gaps in case management and makes decisions to refine SOP’s and processes as needed</li><li>Work with safety physicians on medical review of safety information for regulatory documents (Clinical Study Reports, Investigator's Brochures, Periodic Safety Update Reports)</li><li>Oversight for case management CRO management and ensures that the CRO is providing high quality and efficient post-marketing adverse event case management</li><li>Serve as a training resource on safety-related issues to investigators and across Amylin</li><li>Maintain a comprehensive understanding of the safety profile for respective compounds used in Amylin clinical trials</li><li>Manage the day-to-day aspects of safety agreements with licensing and/or collaboration partners. Work with the Legal department on terms of contracts</li><li>Foster a seamless exchange of safety information with corporate partners or other cross-functional managers and help further integrate drug safety and improve efficiency within the company</li><li>Cultivate and maintain a synergistic and strategic relationships with Alliance partners, clinical departments, providing feedback and training on safety compliance</li><li>Lead and manage special projects and assignments (AE/PC, LSS PowerUser, pregnancy registry, independent adjudication committee, clinical study adverse event and concomitant medication coding, presentations)</li></ul><p><strong>REQUIREMENTS:</strong></p><ul><li>Bachelor's degree or higher in a scientific or other relevant discipline, or equivalent experience/training from accredited institution. (MD, Pharm.D, PA, NP, MSN)</li><li>Minimum 5 years experience in an equivalent role in a regulated environment.

(Pharmaceutical or Biotechnology)</li><li>Experience in pre-or post approval safety activities, including safety processes and reporting</li><li>Requires solid understanding of Good Clinical Practices and Food and Drug Administration regulatory reporting requirements, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines</li><li>Prior operations experience in managing staff and processes associated with a product safety program is desirable, but not required</li><li>Strong clinical knowledge and strong report writing and communication skills are essential</li><li>Experience of international Pharmacovgilance business highly desired and management experience</li><li>Ability to read, analyze and interpret scientific journals and regulatory documents</li><li>Ability to write reports, medical summaries and procedure manuals</li></ul>

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Amylin Pharmaceuticals helps diabetics gain the upper hand in their battle with the disease. The company makes and markets injectable...