Manager Drug Surveillance

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Job Description
REQUIREMENTS:

* Bachelor's degree in biomedical science or equivalent and a basic knowledge of clinical medicine. Must have three to five years of experience in processing clinical safety data in industry setting. Incumbent must possess solid understanding of federal regulations as they apply to drug surveillance for both IND and NDA reporting. Experience managing safety issues in product specific areas is also desirable.

* Strong communication skills are required in order to facilitate report preparation, participate in working groups and interact with a variety of departments. Experience with computerized data entry and retrieval as well as other computer based applications (word processors/spreadsheets) is also required. In addition, the candidate must possess demonstrated supervisory, analytical and teaching skills and the ability to organize time effectively.

DUTIES & RESPONSIBILITIES:

* Assists in the development of policies and procedures for managing adverse event information and initiates changes as appropriate.

* Develops and implements customized training programs regarding the application of Drug Surveillance SOPs and Federal Regulations to both internal and external personnel involved with the processing of drug safety information.

* Directly responsible for resolving day to day issues related to adverse event reports received from both marketed and investigational use.

* Manages documentation, electronic storage, timely reporting and follow-up adverse event case reports at each step of the process.

* Ensures the processing of adverse event reports in a timely fashion as specified by Federal Regulations and departmental SOPs. This involves the analysis and classification of reports, data entry, coding of data, clarification of questions with appropriate personnel, in-house circulation and organization of case files.

* Oversees the follow-up of adverse event reports by fax, telephone and mail from the appropriate individuals to ensure completeness of files.

* Monitors the status of expedited adverse event reports to ensure timely reporting to the FDA. (D)

* Works with other departments to ensure consistent, accurate and timely reporting of adverse event information.

* Utilizes all available resources to analyze adverse event reports including existing computer programs to query the database and create reports.

* Completes, reviews and signs off on periodic NDA and annual IND reports (safety section) for products in therapeutic area.

* Reviews protocols, case report forms, clinical trial reports, other summary safety documents and contractual agreements for therapeutic area.

* Participates in project team meetings and acts as contact within Drug Surveillance regarding adverse event reporting procedures, coding issues, conventions and summary reports for therapeutic area. (C)

* Performs final review and resolves issues related to safety assurance review at clinical trial completion, including review of coding and reconciliation between clinical and safety databases for therapeutic area.