Post Market Surveillance Specialist
Mallinckrodt Pharmaceuticals
Summary
The Post Market Surveillance Specialist is responsible for supporting product monitoring and post-market surveillance activities through collection, trending, analysis, and reporting of product quality and performance data. This role performs complaint trending, product performance metric analysis, literature reviews, recall support activities, and regulatory reporting support to ensure compliance with global quality system requirements and applicable regulatory standards.
Job description
The position works closely with a cross-functional team to identify emerging trends, support continuous improvement initiatives, and ensure effective monitoring of product performance throughout the product lifecycle. This role reports to the Director of Product Monitoring and collaborates closely with the Sr. Post Market Surveillance Specialist, Manager/Sr. Manager of Product Monitoring, and Complaint Analysts.
Job Description
- Perform quality metrics and trending analyses for complaint data, including complaint timeliness, lot trending, complaint category trending, and root cause trending presented during Product Performance Management and Management Review meetings.
- Prepare, analyze, and present complaint trending data, product performance metrics, and post-market surveillance information to support annual drug and device reports.
- Escalate identified complaint trends, safety signals, or Drug-1 complaints in accordance with company procedures.
- Complete literature reviews to identify potential product quality complaints, adverse events, or safety-related information relevant to marketed products.
- Support product recall activities, including preparation of regulatory documentation, maintenance of reconciliation records, and communication with consignees.
- Initiate document change controls and support revision of standard operating procedures, work instructions, forms, and related quality documents.
- Differentiate and appropriately route product quality complaints, adverse events/incidents, medical information requests, customer feedback, and regulatory agency inquiries.
- Capture, review, analyze, and trend product quality complaint data to identify emerging risks and opportunities for continuous improvement.
- Comply with applicable global regulations, standards, and internal procedures regarding the receipt, review, investigation, and reporting of product experiences.
- Collaborate effectively with cross-functional stakeholders, including R&D, Engineering, Quality, Operations, Medical Affairs, Technical Services, Product Support, Clinical Services, and Customer Care to evaluate complaint data and product performance.
- Generate, maintain, and distribute complaint database reports, scorecards, dashboards, and surveillance metrics.
- Provide support during internal audits, external audits, and regulatory inspections, including preparation of metrics, documentation, and responses to requests.
- Support continuous improvement initiatives related to complaint handling, surveillance processes, reporting, and data analytics.
- Perform other duties as assigned.
Qualifications
Education
- Bachelor's degree in Science, Engineering, Mathematics, Business, or a related discipline.
Experience
- Minimum 4 years of experience in medical device, biologics, and/or pharmaceutical manufacturing.
- Minimum 1 year of experience performing data analysis and trending activities.
- Experience with complaint management and post-market surveillance preferred.
Preferred Skills
- Strong analytical, organizational, problem-solving, and time-management skills.
- Advanced proficiency with Microsoft Excel, including pivot tables, formulas, and data analysis.
- Proficiency with Power BI, including dashboard development, data visualization, and analysis of complaints, product performance, and post-market surveillance data.
- Proficiency with Microsoft Word and PowerPoint.
- Knowledge of complaint handling processes, trending methodologies, and post-market surveillance requirements.
- Knowledge of applicable regulations and standards (21CFR 820, 21CFR 803, 21CFR 210/211, EU MDR, MDSAP, ISO 13485, CMDCAS, etc.).
- Ability to read and interpret scientific, medical, and technical literature.
- Excellent written, verbal, and presentation skills.
- Ability to communicate effectively with technical and non-technical personnel across all organizational levels.
- Experience preparing metrics and executive-level reports for management review and regulatory reporting activities.
- Ability to work independently while managing multiple priorities in a fast-paced environment.
Requirements
- Bachelor's degree in Science, Engineering, Mathematics, Business, or a related discipline.
- Minimum 4 years of experience in medical device, biologics, and/or pharmaceutical manufacturing.
- Minimum 1 year of experience performing data analysis and trending activities.
- Experience with complaint management and post-market surveillance preferred.
- Strong analytical, organizational, problem-solving, and time-management skills.
- Advanced proficiency with Microsoft Excel, including pivot tables, formulas, and data analysis.
- Proficiency with Power BI, including dashboard development, data visualization, and analysis of complaints, product performance, and post-market surveillance data.
- Proficiency with Microsoft Word and PowerPoint.
- Knowledge of complaint handling processes, trending methodologies, and post-market surveillance requirements.
- Knowledge of applicable regulations and standards (21CFR 820, 21CFR 803, 21CFR 210/211, EU MDR, MDSAP, ISO 13485, CMDCAS, etc.).
- Ability to read and interpret scientific, medical, and technical literature.
- Excellent written, verbal, and presentation skills.
- Ability to communicate effectively with technical and non-technical personnel across all organizational levels.
- Experience preparing metrics and executive-level reports for management review and regulatory reporting activities.
- Ability to work independently while managing multiple priorities in a fast-paced environment.
Benefits
- Competitive pay
- Bonus program
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
Company overview
Mallinckrodt Pharmaceuticals is a global specialty pharmaceutical company founded in 1867 with headquarters in Dublin, Ireland, and operational headquarters in the United States. The company develops, manufactures, markets, and distributes specialty pharmaceutical products and therapies across two main segments: Specialty Brands and Specialty Generics. The Specialty Brands segment focuses on autoimmune and rare diseases in areas such as neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology, as well as immunotherapy, neonatal respiratory critical care therapies, analgesics, and gastrointestinal products. The Specialty Generics segment includes specialty generic drugs and active pharmaceutical ingredients. Mallinckrodt is particularly known for its flagship product Acthar Gel, a naturally sourced complex mixture of adrenocorticotropic hormone analogs used to treat various autoimmune disorders and medical conditions known to cause inflammation. The company has approximately 1,001-5,000 employees worldwide and operates with a direct sales presence in roughly 50 countries. Mallinckrodt has faced significant legal challenges related to opioid litigation and pricing controversies surrounding Acthar Gel, leading to bankruptcy filings in 2020 and 2023. In 2025, the company announced a merger with Endo to create a larger, diversified pharmaceuticals leader.