DRUG SAFETY SURVEILLANCE SPCLS

A Medical Information Specialist is primarily responsible for providing technical and clinical information regarding product usage and performance. Additionally they monitor the safety, quality and efficacy of products marketed and sold by the Mallinckrodt Imaging and Pharmaceutical divisions. As a result of these activities, they will frequently develop, preserve and strengthen customer relationships which is a necessary and expected commodity in today's competetive pharmacuetical and medical device industries. The specialist will establish and maintain positive and mutally rewarding relationships with internal and external customers.rovide clinical and technical support of marketed pharmaceutical products and medical devices.2. Composing and maintaing standardized response letters for internal and external customers. 3. Conduct trend analysis on clinical and technical inquiries of marketed pharmaceutical products and medical devices4. On-going independent review of medical/scientific literature on Mallinckrodt and its competitors' marketed pharmaceutical products and medical devices. Retrieve, disseminate and archive pertinent data as needed to internal and external customers.5. On-going independent critical review of medical/scientific literature on Mallinckrodt and its competitors' marketed pharmaceutical and medical devices to ensure that the information includes adequate and well-controlled studies.6. Review serious adverse event cases and composing summary reports for periodic adverse event reporting to the FDA.7. Provide product performance expertise on cross-functional project teams as necessary.8. Participate in teams concerned with development or support of products as necessary.9. Provide adjunct support with regards to the training of Sales personnel as requested. This may include but is not limited to the areas of Pharmacology, Pharmacokinetics and Pharmacy Practice.10. Based on Department resourcing and business needs, the following additional functions are included: Capture, review and analyze customer usage reports. Follow up on customer usage reports as necessary. Conduct trend analyses in order to provide and alert to changing safety and efficacy profiles on regular and ad-hoc basis. Prepare and deliver accurate reports of continuing product performance for Corporate Quality and other departments of Tyco Healthcare Mallinkcrodt. Identify potential product performance issues and alert appropriate management personnel when needed. Initiate and coordinate investigations for complaints.11. Comply with relevant global product quality related guidelines, standards and regulations regarding the receipt, review, investigation, and reporting of product usage experiences.12. Provide oversight of customer usage experiences, field feedback reports, and professional consultation in matters related to safety, efficacy, and proper product functioning.13. Work in conjunction and effectively communicate with various departments, including Legal Affairs, Regulatory Affairs, R & D, Engineering, Marketing, Sales and Customer Service.Other duties as assigned:Log and track complaints, inquiries and adverse drug events using a computerized data base.Maintain professional licensure in accordance with State and Federal Laws as needed depending on profession.Requirements: Healthcare Professional - education required: PharmD, R.Ph. PA or advanced degree in relevant medical specialty.A minimum of five years of clinical/practical experience in a relevant clinical environment is preferred but not required.Previous Regulatory Affairs, Quality Assurance, and or Medical Affairs experience in the pharmaceutical and/or medical device industry is preferred but not required.Knowledge of the clinical area, including products, procedures and the scientific and medical literature.Advanced scientific literature search and evaluation skills.Knowledge of FDA regulations and guidances in the area of complaint handling,adverse drug event reporting and DDMAC for pharmaceutical products and medical devices.Experience interacting with regulatory agencies such as the FDA.Writing skills necessary to effectively communicate technical/clinical information to others.Knowledge of appropriate guidelines for medical writing; proper formatting of references, citations, etc.Comfortable and capable of using software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.Superior verbal communication skills including impecable telephone etiquette.Problem solving and analytical skills.An ability to effectively integrate customer and business needs in a satifactory manner.Sound organizational skills with the ability to prioritize tasks.Ability to build productive relationships with personnel within and outside of the department and company.Ability to work effectively in multi-functional teams.Medical Information Specialists report directly to the Manager, Product Monitoring and Medical Information.In the process of complaint handling and investigation, the incumbent will be in close contact with Quality Assurance personnel at the manufacturing site of the product(s) in question. Additionally, the incumbent will interact with a variety of Corporate Divisions. These include, but are not limited to, Legal Affairs, Regulatory Affairs, Medical Affairs, R & D, Engineering, Nuclear Pharmacy Operations, Marketing, Quality Assurance, Sales, and Customer Service. The degree and scope will vary according to the needs of the departments involved. To apply online, please use the following link: Apply To Covidien Click here to see all “Covidien� opportunities Visit our web site to learn more about Covidien EMAIL THIS JOB TO A FRIENDCOVIDIEN, COVIDIEN with Logo and "positive results for life" are trademarks of Covidien AG. ©2007 Covidien AG or its affiliate. All rights reserved.