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WHAT
IN
Associate Medical Director of Drug Safety
Job
Talecris Biotherapeutics
US
-
Clayton,
North Carolina
Job Code - 4062
Position - Full - Time Regular
Job First Active on: Monday, November 02, 2009
APPLY TO THIS JOB (You will be applying directly to Talecris Biotherapeutics for this position!)
JOB DESCRIPTION: Associate Medical Director of Drug Safety
1. Assess adverse drug events with respect to seriousness, relationship to drug product, and global labeling status (expected or unexpected) in order to assign appropriate case reporting status.
2. Monitors the collection, processing, review, and distribution of adverse event information regarding assigned developmental and marketed Talecris pharmaceutical products.
3. Assure the accuracy of adverse event information, for assigned products, in the global database, and timely distribution of case information to Global Drug Safety.
4. Establish and maintain close liaison with Global Drug Safety personnel in assigned product areas.
5. Serve as Safety Assurance liaison to clinical development groups and project teams, for assigned products, for review of clinical trial protocols, investigator brochures, investigator training in Drug Safety, and study safety reviews.
6. Develop and maintain in-depth knowledge of assigned pharmaceutical products.
7. Prepare and submit periodic safety reports to U.S. Regulatory authorities (FDA) for assigned products.
8. Conduct periodic review of safety labeling for assigned products,
particularly with regard to current product periodic safety update reports (PSURs), for the purpose of updating U.S. package inserts as required.
9. Consults in the training and development of Drug Safety personnel.
10. Provide training in Drug Safety issues for Talecris Clinical Groups, Clinical Communications, and Sales Staff.
11. Reviews NDAs, INDs, annual reports, study protocols, amendments, clinical research reports, and other documents for accuracy and appropriateness of language concerning safety procedures and results.
REQUIREMENTS - QUALIFICATIONS: Associate Medical Director of Drug Safety
Incumbents with a MD degree must have 2-3 years experience. Incumbents with an
advanced degree (PhD, DVM or PharmD) in a life-science discipline with four to six years of pharmaceutical industry experience (or equivalent), or M.S./M.A. in one of the life sciences (or professional certification/license in a health care profession, or equivalent professional experience) with six to nine years of pharmaceutical industry experience. Three to five years of drug safety experience (either in a drug safety department or equivalent clinical setting) is required. Must have in-depth knowledge in at least one therapeutic area where Talecris drug products are marketed or in development. The incumbent will be capable of assessing the clinical significance of adverse events, and their ramifications for product use. Must be conversant with FDA and international regulations governing drug safety reporting.
Must be facile with computer techniques, particularly the global database system operation and management. The incumbent must be a skilled communicator and team player, particularly in the development and maintenance of cooperative liaisons with internal customers in Talecris Medical Affairs, Regulatory, Legal, and Sales/Marketing, as well as Global Drug Safety personnel in all issues affecting assigned product responsibilities. Must have solid problem solving skills applicable in a diverse work environment. The incumbent must be capable of maintaining currency in the field of pharmaceutical drug safety through participation in workshops, seminars, courses, literature, or other means consistent with an annual developmental action plan.
Talecris Biotherapeutics
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