Drug Safety Manager
Location: Skillman New Jersey
Description: Fladger Associates is in need of Drug Safety Manager right now, this occupation will be placed in New Jersey. For complete informations about this occupation opportunity please read the description below. Responsibilities : · Oversight of case management and regulatory reporting activities for Consumer monograph, cosmetic and medical device products.
- This individual will esta! blish Quality Assurance / Quality Control procedures to ensure quality of processed cases meets required targets, is consistent and accurate with source documents and is compliant with applicable procedures/guidelines.
- Monitor regulatory submission compliance metrics and initiates non-conformance with defined corrective and preventative actions to remediate.
- The candidate will lead MedDRA Coding Team, upgrades to MedDRA and subsequent training of processing team.
- Lead identification and development of user requirements for reports to be developed / validated for use in Remetrex Safety System.
- Will develop and deliver training to Safety Associates and Product Vigilance Physicians.
- Additionally will participate in cross-functional teams to ensure operational alignment of system and process priorities, monitor key performance indicators to identify and implement process efficiencies and quality improvements, and develop controlled d! ocuments as required.
- Provide subject matter expertis! e on case processing and safety database during health authority inspections.
- A minimum of a bachelor's degree and 5 years experience in Pharmacovigilance Operations or related industry activities or a nursing degree / RN and 5 years Pharmacovigilance Operations experience related industry activities OR an Master's degree, MPH or PharmD and 3 years Pharmacovigilance Operations experience related industry activities is required.
- 3 years of managerial experience is preferred.
- A process excellence green belt or higher is preferred.
- Demonstrated experience working in a matrix environment leading cross functional teams is required.
- Working knowledge of AE safety databases to identify systems enhancements and efficiencies is preferred.
- Experience auditing case processing is preferred.
- The ability to provide subject matter expertise in Pharmacovigilance and global AE regulatory report! ing requirements for drugs, devices, and cosmetics is required.
- The ability to develop and /or oversee development of performance and quality metrics for the monitoring of the day-to-day AE case processing and regulatory reporting activities is required.
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Fladger Associates.
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This occupation starts available on: Sun, 17 Mar 2013 18:05:16 GMT