Product Safety Specialist Job in Rockville, Maryland US
COMPANY INFO:
NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Product Safety Specialist
Our client is developing leading positions in seven major therapeutic areas.
Description:
The Safety Specialist is responsible for ensuring accuracy and completeness of safety reports; maintenance of cases in the safety database; and compliance to regulatory reporting obligations. Complete Description:
• Management of CRO safety staff as appropriate to ensure that safety-related project milestones are met within required timelines.
• Ensuring complete case compilation by acquisition of all relevant event information, data entry and maintenance of cases in safety database, development of safety data collection forms and tracking reports, reconciliations of serious adverse events between the safety and clinical study databases, and summarization of serious cases for regulatory authorities and business partners.
• Coordination of preparation of data for safety review committees including, relevant cumulative listings/tables, product profile and case summaries, and analyses based upon safety review committee recommendations.
• Keeping current regarding proposed changes to domestic and international safety reporting requirements and making required changes to processes and systems.
• Participate in the development of product Risk Management Plans (RMPs)
• Participation in the selection, validation, implementation, and training on safety software and other processes in collaboration with managers, and other departments.
• Contributing to development of standard operating procedures for core safety surveillance processes.
• Maintenance of safety files and documentation that are compatible with the corporate document management system.
• Review of product and class safety information including pre-clinical, clinical and post-marketing data from internal and external sources.
• Function as a Product Safety representative at product team meetings as appropriate.
• Contribute to timely and accurate communications with other parts of the organization regarding expedited safety reports, product safety risk management and compliance.
• Solid knowledge of applicable domestic and international safety reporting requirements.
• Experience with medical writing and summarization of clinical safety information is required.
Behavior Characteristics:
• Excellent oral and written communication skills
• Ability to manage several high-priority activities
• Ability to work independently with minimal supervision, but seek appropriate involvement from senior management
KEYWORDS:
Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor
MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
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