Vacancy has expired
Show me jobs like this one| Job Ref: | 8472BR |
| Sector: | Pharmaceutical and Medical Device |
| Job Type: | Full Time |
| State: | Illinois (IL) |
| City: | Lake Forest |
| Post Code: | Jan 17, 2012 |
| Job Description: |
Review and evaluate any drug and/or device safety issues and ensure compliance with worldwide regulations and/or guidelines. Provide medical approval and validation of safety reports (as defined by SOP's), including post-market events, clinical events, and periodic reports.Major Duties and Responsibilities: Oversee the process and completion of medical assessment of both drug and device product safety reports including clinical, literature and post marketing adverse event reports.Generate, author, and/or review product safety reports as required by the worldwide regulatory agencies by developing safety data retrieval strategy and assessing the significance of relevant safety information. Provide trending and safety signal detection supervision by monitoring and analyzing qualitative nature, frequency, and severity of drug and/or device safety case reports.Oversee the development, approval and issuance of drug and device core information, local device labeling and recommend changes from scientific inputs when necessary. Perform analysis and final review of the drug periodic/PUSR reports. Recommend and review label changes as necessary. Provide assistance, guidance, and mentoring to Regulatory Reporting Specialists, Periodic Reporting Specialists and Risk Management Specialists. Perform product risk/benefit or health hazard analysis and assessment to aim appropriate regulatory actions for drug and/or device safety and/or quality issues. Perform product risk assessments as part of the creation of a Risk Management Plan for high risk products and make recommendations to the core safety and product labeling as part of the fulfillment of the Pharmacovigilance function, The risk assessment will follow the guidance documents from applicable regulators (FDA and EU). This will include the development and use of tools such as Post Market Surveillance studies, Meta-Analysis, Analysis of medical publications to gain further insight into the interactions of our products in use with the intention to reduce the overall risk. Fulfill the role of clinical product safety oversight by reviewing the proposed clinical protocol, review and triage the clinical safety reports and perform data reconciliation. Requirements MD (Physician) credentials required for the appropriate level review, authority, and validation of assessments, guidance, and direction regarding risk and safety factors of Hospira's drug and device products with a minimum of two years of experience in the pharmaceutical/health care industry in the functional area of drug and/or device safety. |
| Post Date: | 01/18/2012 |
