Associate Director, Global PV Product Complaint Management & Oversight

United Therapeutics Corporation•RTP, NC, NC

4d•Hybrid

About The Position

We are looking for an Associate Director, Global PV Product Complaint Management & Oversight to lead and elevate global Product Complaint Safety governance structure across devices, drugs, combination products, and biologics at a local US and global level at all product life cycles. This position provides direction to the team and vendors with respect to PC Handling/business practices for efficiency, quality, and compliance impacts. The ideal candidate is a confident, collaborative PV and product complaint leader who can turn complex requirements into practical solutions that protect patients and strengthen compliance. This role ensures that operational aspects of the safety data collected and processed and assessed as product complaints are managed with rigorous global standards in proper documentation, evaluation processes, and decisions to support the overall global safety surveillance program and proper management of benefit/risk of UTC products in accordance with EU MDR requirements, combination reporting requirements (21 CFR 820 and 211), IMDRF requirements, ISO 13485 (quality management systems), ISO 14971 (risk management), IEC 62304 (medical device software), and ISO 10993 (biological evaluation). Functions as horizontal enterprise leader who optimizes and oversees the product complaint governance, inspection readiness, and regulatory compliance across the Product Complaint Safety lifecycle by influencing and implementing strategic initiatives address internal and external business and regulatory issues; Anticipate potential internal and/or external business challenges or regulatory nuances and recommend solutions Design, develop and implement globally harmonized procedures, training materials, and process requirements necessary to support PC handling activities; make operational decisions and provide recommendations related to safety practices/requirements, policies, programs, and compliance activities Evaluate and implement business process changes in response to regulatory updates to ensure the effectiveness PC handling process for drugs, combination products, and/or biologics at a local and global level Initiate, plan, coordinate updates current process, to ensure coverage with new products and compliance with GVP, IMDRF and other regulatory requirements to ensure compliance Responsible for establishing, maintaining and compliance the global product complaint process framework, including policies, standards, procedures, process maps, escalation pathways, and role clarity (i.e. RACI) Oversee day-to-day procedural quality and compliance of end-to-end PC handling activities, including entry within GSD, initiation within QMS, RGA processes, and related activities; Maintain PC operating procedures, including date entry guideline, coding conventions and monitor systems to ensure PCs, MDRs, malfunction reports, FARs, and BPDRs are processed and submitted per SOPs. Review and approve SOPs related to PC handling activities to support the global safety surveillance program/proper management of benefit/risk of UTC products; Establish and maintain risk-based oversight models to ensure PC compliance with global pharmacovigilance regulations, contractual obligations, and company standards Ensure all product complaints are managed in accordance with applicable global regulations, company quality standards, and internal procedures (e.g., 21 CFR 211.198, EU GMP Chapter 8, ICH Q10, 21 CFR 820.198, 803 (MDR), IMDRF guidelines, and EU MDR/IVDR vigilance requirements). Maintain current knowledge of regulations, guidelines, and industry best practices related to PC handling, investigations, and MDR reporting; Evaluate emerging regulatory, operational, and business risks associated with PC handling and reporting activities and develop mitigation plans; Assess the impact of regulatory changes and implement necessary process, system, and governance updates; Monitor Key Process Indicators (KPIs) and compliance metrics to ensure adherence to global reporting timelines (e.g., FDA, EMA, and ISO standards) Serve as the primary escalation point for PC handling, combination reporting, MDR reporting, compliance, governance, quality, and safety-related operational issues; Recommend improvements to PC oversight programs, governance processes, quality systems, and operational processes. Lead process reviews and governance forums to assess process effectiveness, compliance, resource, and opportunities for continuous improvement Develop and deliver training and training materials for PC handling in accordance with SOPs, global regulations, guidelines, and industry standards; Provide training and education in conjunction with the Brand Safety Lead (BSL) and the product FMEAs regarding potential product complaints and user issues Lead cross functional initiatives to strengthen inspection readiness, compliance, and operational effectiveness; Act as the point of contact for inspections and audits related to Global Product Safety (GPS) product complaint handling activities; Conduct root cause analysis of inspection or audit findings and ensure appropriate CAPAs are implemented; Review and approve deviations and CAPAs for any related activity as needed Develop, implement, and maintain new or revised SOPs; Update and maintain procedural documents related to GPS PC Operations, workflows, and PVAs; Lead strategic improvement initiatives to strengthen the effectiveness, efficiency, and control of the product complaint process/lifecycle; Partner with Quality Systems and/or IT/GPS Systems and Analytics team to define business requirements and optimize digital tools/workflows supporting complaint management Direct and manage direct reports to include training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process, as needed Exercise independent judgement when evaluating complex compliance issues, safety reporting challenges, inspection observations, and regulatory risks; Balance patient safety, regulatory obligations, business objectives, operational feasibility, and organizational risk Perform other duties as assigned

Requirements

Bachelor’s degree in a related field or BSN
12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs or product complaint handling with a bachelor's degree
10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs and/or PC handling with a master's degree
7+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs and/or PC handling with a PharmD or international equivalent
4+ years of experience supporting devices, biologics, drug products, and/or combination products in local and/or global environments
5+ years of experience working with vendors on implementing and oversight of product complaint processing including IMDFR and other regulatory guidance implementation
3+ years of product development and/or post-marketing drug exposure experience (all products - drug, device, combination products, biologics…)
Previous functional lead/people management experience
Clinical and post marketing experience
Experience using Argus (preferred) or other safety databases
Strong knowledge of cGMP, GDP, QSR, ISO 13485 (quality management systems), ISO 14971 (risk management), IEC 62304 (medical device software), ISO 10993 (biological evaluation), IMDRF requirements and Pharmacovigilance interfaces
In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
Strong written and verbal communication skills with the ability to communicate safety issues to diverse audiences
End-to-end case processing (including data entry, QC, medical review, regulatory submissions)
Project management skills and ability to organize and deliver large, complex projects independently
Working knowledge of drug development processes and applicable regulatory requirements related to the development and registration of medicines
Strong analytical skills to assess issues, evaluate information, and recommend solutions
Ability to work effectively across functions; understands objectives, activities, and required contributions of internal partner functions
Is adaptable and can work effectively in ambiguous situations
Willing and able to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
Working knowledge of MedDRA coding
Working knowledge of global regulations, guidelines and industry best practices for end-to-end case management for devices, biologics, combination products and drug products

Nice To Haves

Master’s degree in a related field
Doctor of Pharmacy (PharmD)

Responsibilities

Lead and elevate global Product Complaint Safety governance structure across devices, drugs, combination products, and biologics at a local US and global level at all product life cycles.
Provide direction to the team and vendors with respect to PC Handling/business practices for efficiency, quality, and compliance impacts.
Ensure operational aspects of safety data collected, processed, and assessed as product complaints are managed with rigorous global standards in proper documentation, evaluation processes, and decisions.
Functions as horizontal enterprise leader who optimizes and oversees the product complaint governance, inspection readiness, and regulatory compliance across the Product Complaint Safety lifecycle.
Influences and implements strategic initiatives to address internal and external business and regulatory issues.
Anticipates potential internal and/or external business challenges or regulatory nuances and recommends solutions.
Designs, develops, and implements globally harmonized procedures, training materials, and process requirements necessary to support PC handling activities.
Makes operational decisions and provides recommendations related to safety practices/requirements, policies, programs, and compliance activities.
Evaluates and implements business process changes in response to regulatory updates to ensure the effectiveness of the PC handling process for drugs, combination products, and/or biologics at a local and global level.
Initiates, plans, and coordinates updates to current processes to ensure coverage with new products and compliance with GVP, IMDRF, and other regulatory requirements.
Establishes, maintains, and ensures compliance of the global product complaint process framework, including policies, standards, procedures, process maps, escalation pathways, and role clarity (i.e. RACI).
Oversees day-to-day procedural quality and compliance of end-to-end PC handling activities, including entry within GSD, initiation within QMS, RGA processes, and related activities.
Maintains PC operating procedures, including date entry guidelines, coding conventions, and monitors systems to ensure PCs, MDRs, malfunction reports, FARs, and BPDRs are processed and submitted per SOPs.
Reviews and approves SOPs related to PC handling activities to support the global safety surveillance program/proper management of benefit/risk of UTC products.
Establishes and maintains risk-based oversight models to ensure PC compliance with global pharmacovigilance regulations, contractual obligations, and company standards.
Ensures all product complaints are managed in accordance with applicable global regulations, company quality standards, and internal procedures.
Maintains current knowledge of regulations, guidelines, and industry best practices related to PC handling, investigations, and MDR reporting.
Evaluates emerging regulatory, operational, and business risks associated with PC handling and reporting activities and develops mitigation plans.
Assesses the impact of regulatory changes and implements necessary process, system, and governance updates.
Monitors Key Process Indicators (KPIs) and compliance metrics to ensure adherence to global reporting timelines.
Serves as the primary escalation point for PC handling, combination reporting, MDR reporting, compliance, governance, quality, and safety-related operational issues.
Recommends improvements to PC oversight programs, governance processes, quality systems, and operational processes.
Leads process reviews and governance forums to assess process effectiveness, compliance, resource, and opportunities for continuous improvement.
Develops and delivers training and training materials for PC handling in accordance with SOPs, global regulations, guidelines, and industry standards.
Provides training and education in conjunction with the Brand Safety Lead (BSL) and the product FMEAs regarding potential product complaints and user issues.
Leads cross-functional initiatives to strengthen inspection readiness, compliance, and operational effectiveness.
Acts as the point of contact for inspections and audits related to Global Product Safety (GPS) product complaint handling activities.
Conducts root cause analysis of inspection or audit findings and ensures appropriate CAPAs are implemented.
Reviews and approves deviations and CAPAs for any related activity as needed.
Develops, implements, and maintains new or revised SOPs.
Updates and maintains procedural documents related to GPS PC Operations, workflows, and PVAs.
Leads strategic improvement initiatives to strengthen the effectiveness, efficiency, and control of the product complaint process/lifecycle.
Partners with Quality Systems and/or IT/GPS Systems and Analytics team to define business requirements and optimize digital tools/workflows supporting complaint management.
Directs and manages direct reports to include training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provides support for recruitment process, as needed.
Exercises independent judgment when evaluating complex compliance issues, safety reporting challenges, inspection observations, and regulatory risks.
Balances patient safety, regulatory obligations, business objectives, operational feasibility, and organizational risk.
Performs other duties as assigned.