Manager, Product Safety Evaluation (1 of 2 positions)-6705130108
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Manager, Product Safety Evaluation, located in Horsham, PA.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Manager, Product Safety Evaluation assists and supports the medical and scientific functions within Global Medical Safety (GMS) with safety evaluations for assigned products. Such tasks include preparation and coordination of reviews of individual case safety reports as well as aggregate safety data. The Manager, Product Safety Evaluation will also participate in Safety Management Team (SMT) meetings and support related activities.
Responsibilities of the Manager, Product Safety Evaluation include: participate in preparation, analysis and writing of ad hoc and aggregate regulatory reports and labeling support documents, collect and/or organize the data collected as part of product recalls and surveillance activities, manage outsourced data collection, organization preparation with vendors as required, support surveillance activities (vendors, consultants, and databases) and assist with contracts, proposals and data sharing, collation of draft reports, progress reports required for updating Health Agencies of RMP/REMS activities, attend SMT meetings and any support related activities, assist in organizing or running searches of safety or regulatory databases and provide support to related pharmacovigilance activities such as preparation of reports for surveillance support and collating reports for review of product quality data, support of health hazard evaluations, scientific presentations etc.
A minimum of a Bachelors Degree in biological sciences AND a minimum of 5 years of drug safety (Pharmacovigilance) experience, with at least 1 year of safety data analysis/review, drafting/writing of ad-hoc regulatory and aggregate reports, labeling and related documents (HHE, etc) is required for this position. An advanced academic degree in biological or natural science or health-care discipline (e.g. MS, MPH, Pharm. D etc) AND a minimum of 2 years of pharmaceutical industry experience is preferred.
The Manager, Product Safety Evaluation must possess an understanding of medical concepts and the ability to medically assess safety data. The ability to interpret, analyze and clearly present scientific and technical data in verbal and written format is required. Strong writing skills is essential for success in this position.
Familiarity with industry principles of drug safety is required and familiarity with industry principles of drug development, pharmacology, biostatistics, and pharmacoepidemiology are preferred. Advanced knowledge of Microsoft Excel and Microsoft Word are required.
The Manager, Product Safety Evaluation is a team player with the ability to work under tight timelines and manage high workload and critical issues with poise. Strong internal and external networking skills and the ability to thrive in a global, matrix environment is necessary for success.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location: North America-United States-Pennsylvania-Horsham
Organization: Janssen Research & Development, LLC. (6084)
Johnson & Johnson Family of Companies
- 2 years ago - save job
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