Post Market Surveillance Specialist
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. 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
- 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.
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.
Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova.
The expected base pay range for this position is $61k– $98k. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.
This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.
At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.
We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.
We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.
Post Market Surveillance Specialist
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. 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
- 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.
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.
Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova.
The expected base pay range for this position is $61k– $98k. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.
This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.
At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.
We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.
We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.
