Watch for similar jobs
Analyst, Global Product Surveillance & Safety Job
Date: Nov 5, 2009
Location: Aliso Viejo, CA, 92653, USA
Job Title:
Analyst, Global Product Surveillance & Safety
Req #:
5365BR
Job Description:
Position Summary Position focus is on processing product complaints from receipt to closure, including making reportability assessments, handling follow-up on complaint information, and communicating with other departments and upper management. Specific Job Duties The individual must be able to perform the following duties: .Ability to interact with team members within GPSS department, supporting departments and management at different levels. .Responsible for receiving and documenting domestic and international complaint files. .Ability to perform data entry, create file folders, labels, letters, file, fax, scan, and associated duties as required. .Ability to make adverse event reporting determinations to meet FDA, and international regulatory requirements .Responsible for follow-up of complaint process from initiation to completion with respect to: additional contact with complainant via phone/fax/email/letter(s) to clarify or obtain additional information, DHR review, product investigation, and root cause analysis. .As required, participate in training, projects, and/or other complaint related activities to resolve complaint(s) .Ability to interpret, follow and make required revisions to standard operation procedures required .Compile, review and close complaint files .Assist with special projects as required
Qualifications
.Position requires a minimum of 3 -5 years related work experience. .A bachelor's degree in a science related field is strongly preferred, however a combination of education and work experience in place of degree will be considered. Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance reporting regulations, GMPs, ISO Std's for medical devices preferred. .Position requires strong written, oral and listening communication skills in order to interact with internal/external customers and other professionals. The ability to generate and organize clear, concise responses at different levels of management is required. .Proficiency in the use of personal computers is required, including complaint database management, trending and word processing.
Work Location CA - Aliso Viejo Relocation Available No
Status Full-Time
Analyst, Global Product Surveillance & Safety
Req #:
5365BR
Job Description:
Position Summary Position focus is on processing product complaints from receipt to closure, including making reportability assessments, handling follow-up on complaint information, and communicating with other departments and upper management. Specific Job Duties The individual must be able to perform the following duties: .Ability to interact with team members within GPSS department, supporting departments and management at different levels. .Responsible for receiving and documenting domestic and international complaint files. .Ability to perform data entry, create file folders, labels, letters, file, fax, scan, and associated duties as required. .Ability to make adverse event reporting determinations to meet FDA, and international regulatory requirements .Responsible for follow-up of complaint process from initiation to completion with respect to: additional contact with complainant via phone/fax/email/letter(s) to clarify or obtain additional information, DHR review, product investigation, and root cause analysis. .As required, participate in training, projects, and/or other complaint related activities to resolve complaint(s) .Ability to interpret, follow and make required revisions to standard operation procedures required .Compile, review and close complaint files .Assist with special projects as required
Qualifications
.Position requires a minimum of 3 -5 years related work experience. .A bachelor's degree in a science related field is strongly preferred, however a combination of education and work experience in place of degree will be considered. Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance reporting regulations, GMPs, ISO Std's for medical devices preferred. .Position requires strong written, oral and listening communication skills in order to interact with internal/external customers and other professionals. The ability to generate and organize clear, concise responses at different levels of management is required. .Proficiency in the use of personal computers is required, including complaint database management, trending and word processing.
Work Location CA - Aliso Viejo Relocation Available No
Status Full-Time
Nearest Major Market: Orange County
Nearest Secondary Market: Los Angeles
Job Segments: Safety, Service
Apply now »
| Find similar jobs: | Bausch & Lomb Jobs, Bausch and Lomb Jobs, Eye Care Jobs, Los Angeles Service Jobs |
« Back to search