Vacancy expired!
- Provides customer service and support to meet the needs of the complainants
- Identifies and confirms inquiries as product technical complaints.
- Evaluates complaints for severity and risk to public safety.
- Notifies interested departments (including manufacturing site QA, commercial, regulatory, supply chain) upon receipt of critical complaints.
- Monitors and tracks sample receipt from critical complaints.
- Ensures complaints are reviewed and processed within a timely fashion.
- Prioritizes complaints for data entry and processing into the department PTC database.
- Utilizes the customer service database to oversee complaint identification and processing.
- Monitors complaint activity for assigned manufacturing sites.
- Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations.
- Identifies complaints for field alert reporting
- Performs QC Checks
- Understands FDA complaint regulations for drug products and medical devices.
- Performs file review and administrative closure for individual complaints.
- Produces and sends monthly reports to responsible manufacturing sites listing monthly complaint activity.
- Monitors open complaint activity for each manufacturing site.
- Interacts with Customer Service, Medical Information, Pharmacovigilance and other company departments/associates regarding the identification and evaluation of technical complaints.
- Identifies and reports adverse events within one business day to Pharmacovigilance.
- Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management.
- Participates on ad-hoc teams regarding product-specific complaint issues.
- Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits.
- Understands product specific information regarding common product complaints.
- Understands department process flows and complaint databases.
- Provides feedback to customers regarding complaint investigations.
- Performs other duties as assigned.
- Minimum of 3 to 5 years of related experience within the pharmaceutical industry.
- Strong Verbal and Written Communication Skills
- Problem Solving Skills
- Adept at Attention to Detail
- Strong understanding of Good Documentation Practices
- Good organizational skills
- Analytical skills
- Self-motivated/directed
- Computer literate—proficient in use of word processors. Must be able to understand and utilize complaint database software and reporting tools.
- Knowledge of cGMPs and Code of Federal Regulations regarding drugs, medical devices, combination products and biologics
- Project and Time Management Skills
- Interpersonal skills-must be proactive, personable, flexible, team-oriented
- Customer Service Skills
- Ability to multitask in a highly stressful environment
- Ability to operate in a constantly changing environment
Vacancy expired!