*Summary*
· Responsible for the investigation of product quality complaints received for commercially distributed and investigational products.
· Facilitate the review of complaint data and investigation reports.
· Coordination of workload to ensure timely completion of investigations.
· Plan and manage projects.
Ensure inspection readiness for complaint investigation related items.
· Ensure process is compliant with regulatory requirements and business needs in terms of receiving, documenting, investigating, resolving, and responding to complaints.
*Key Responsibilities*
· Manages the receiving and handling (documentation, coordination, investigation, resolution, and closeout) of all Product Quality Complaints and patient-related field events in a manner that complies with global regulatory requirements Manages Client’s processes pertaining to contact with healthcare professionals submitting product complaints.
· Reviews completed complaint files to assure proper documentation, coordination, investigation, resolution, and closeout and ensure compliance to regulatory requirements as well as business requirements.
· Creates complaint and related CAPA trend analysis reports and submit to management to ensure early detection of potential quality issues.
· Gathers data to assist with any potential recall and/or reporting actions.
· Participates in internal audits and external quality system audits conducted by regulatory agency representatives.
· Monitors complaints for product trends and notify management of events requiring immediate action.
· Follow-ups with applicable complaint sources (study coordinators, physicians, pharmacies, sales reps, and hospitals) to obtain applicable information pertaining to reported events Support Global Quality continuous improvement activities
*Education and Experience*
· Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, quality management systems, IT systems, training, and education.
Strong knowledge of deviation, investigation and/or complaint management preferred.
Bachelor's degree in a life science required.
At least 7 years of pharmaceutical experience with increasing levels of leadership responsibility Proven leader with exceptional problem solving and communication skills, with the ability to influence across all levels and functions within the organization.
Job Type: Contract
Salary: $60.
00 - $65.
00 per hour
Expected hours: 40 per week
Benefits:
* 401(k)
* Dental insurance
* Health insurance
* Vision insurance
Experience level:
* 11+ years
* 9 years
Schedule:
* Monday to Friday
Experience:
* veeva Vault: 6 years (Required)
* Compliance management: 10 years (Required)
Work Location: Remote
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