QA/Pharmacovigilance Specialist I - Collins Consulting Inc
Austin, TX 78727
About the Job
This is a hybrid position. Will be onsite 100% during training and then will be 3 days in office, 2 remote following training.
Individual will work in the client's global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal the client's customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding the client product complaints. Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events. Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
Responsibilities:
"Assure complaint records meet global requirements.
"Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
"Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
"Identification of potentially reportable events and notification to appropriate functional groups and management.
"Interface with Third Party Manufacturers, health care professionals, general public, internal customers, the client's functional areas and regulatory agencies.
Qualifications:
"Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
"Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
"Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
"Solid written/verbal communication and organizational skills.
"Knowledge and application of computer systems for word processing and complaint management.
"Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
"A Bachelor Degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
"0-3 years work experience in a cGMP related industry or in a clinical setting is preferred
" 1 year quality and/or complaint handling experience.
What are the top 3-5 skills requirements should this person have?
" Detail oriented
" Microsoft Excel Knowledge and Experience sorting, filtering are a must
" Adaptive to change
" Self-starter/independent worker
" Taking initiative to improve/create efficiency
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
" Degree is preferred
" 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.
Individual will work in the client's global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal the client's customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding the client product complaints. Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events. Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
Responsibilities:
"Assure complaint records meet global requirements.
"Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
"Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
"Identification of potentially reportable events and notification to appropriate functional groups and management.
"Interface with Third Party Manufacturers, health care professionals, general public, internal customers, the client's functional areas and regulatory agencies.
Qualifications:
"Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
"Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
"Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
"Solid written/verbal communication and organizational skills.
"Knowledge and application of computer systems for word processing and complaint management.
"Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
"A Bachelor Degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
"0-3 years work experience in a cGMP related industry or in a clinical setting is preferred
" 1 year quality and/or complaint handling experience.
What are the top 3-5 skills requirements should this person have?
" Detail oriented
" Microsoft Excel Knowledge and Experience sorting, filtering are a must
" Adaptive to change
" Self-starter/independent worker
" Taking initiative to improve/create efficiency
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
" Degree is preferred
" 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.
Source : Collins Consulting Inc