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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance within the pharmaceutical industry, focusing on post-market surveillance, complaint handling, and regulatory compliance. Proficient in analyzing product performance and collaborating across multifunctional teams to ensure safety and efficacy.
Highest-signal resume keywords
Quality Assurance ExperiencePost-Market SurveillanceFDA Regulations KnowledgeTechnical Writing SkillsAnalytical Problem-Solving
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ExperiencePost-Market SurveillanceHealth Hazard EvaluationComplaint HandlingRegulatory ComplianceTrend AnalysisProduct Performance EvaluationPharmacovigilanceClinical SupportProcess Improvement
Soft Skills
Verbal CommunicationWritten CommunicationOrganizational SkillsRelationship BuildingTeam Collaboration
Tools & Technologies
WordExcelPowerPointAccess
Industry Keywords
Pharmaceutical IndustryMedical Device IndustryGlobal RegulationsQuality GuidelinesCustomer Feedback
About the role
Key responsibilities & impact- Monitor the safety, quality, and efficacy of products marketed and sold by Par Health
- Receive, capture, and evaluate product feedback reports in accordance with FDA and global regulations and guidelines
- Provide technical and clinical information regarding product usage and performance
- Provide global Quality oversight for field alert reports, health hazard evaluations, and recalls
- Initiate and coordinate health hazard evaluations, field actions, and mock recalls
- Answer and triage incoming calls via the automatic call distribution line
- Review and approve customer complaint response letters
- Capture, review, and analyze customer usage reports
- Follow up on post-market customer usage and field service reports
- Evaluate complaints for potential adverse events and forward them to pharmacovigilance
- Collaborate globally on reports received from outside the US
- Conduct trend analyses of safety and efficacy profiles
- Prepare reports on continuing product performance for Quality and other departments
- Identify product performance issues and alert management
- Initiate and coordinate complaint investigations and support medical inquiries
- Ensure compliance with global product quality guidelines, standards, and regulations
- Oversee customer usage experiences, field feedback, product safety reporting, and professional consultation
- Collaborate with Legal, Regulatory Affairs, R&D, Commercial, Pharmacovigilance, Medical Information, Customer Service, and Manufacturing Sites
- Provide clinical and technical support for marketed pharmaceutical products
- Provide product performance expertise on cross-functional project teams
- Participate in product development and support teams
- Support audits and regulatory inspections
- Lead process improvement initiatives
- Train new hires, site personnel, and sales representatives on post-market reporting practices
- Report to the Manager, Product Monitoring
- Maintain frequent communication with customers, manufacturing QA personnel, Medical Information Specialists, and corporate divisions
Requirements
What you’ll need- Bachelor's degree in chemistry, chemical engineering, or a related science or clinical field
- Minimum of eight years of Quality experience in a pharmaceutical manufacturing environment
- Previous Post-Market Surveillance, health hazard evaluation, or field alert report experience in the pharmaceutical and/or medical device industry is preferred
- Knowledge of FDA regulations and guidances concerning complaint handling for pharmaceuticals, biologics, or medical devices
- Experience interacting with regulatory agencies such as the FDA
- Writing skills to effectively communicate technical/clinical information
- Proficiency with Word, Excel, PowerPoint, and Access, and willingness to expand these competencies
- Excellent verbal and written communication skills and telephone etiquette
- Comfort handling discussions with patients and healthcare providers on health and medical topics
- Problem-solving and analytical skills
- Ability to integrate customer and business needs
- Organizational skills and ability to prioritize tasks
- Ability to build productive relationships within and outside the department and company
- Ability to work effectively in multifunctional teams
Benefits
Comp & perks- Full-time employment
- Hybrid working schedule
- Occasional travel opportunities for training seminars, manufacturing site visits, and professional/trade conventions