Job Title Manager, Product MonitoringRequisitionJR000014045 Manager, Product Monitoring (Open)LocationWebster Groves (Pharma) - USA038Additional LocationsSt. Louis, MOJob DescriptionSUMMARY OF POSITION:Manage the day-to-day processes of complaint handling for products marketed by SpecGx LLC (The Company) while ensuring compliance with FDA and global regulations, guidances and Company policies and procedures for complaint handling by Product Monitoring (PM). Responsible for the coordination of compliance related activities within the Post-Market Surveillance-Product Monitoring (PM) department; this includes, but is not limited to, the management of critical issue such as Health Hazard Evaluation (HHEs), Field Alert Reporting (FARs) and Recalls. Develop, maintain, and continually improve formats for organizing and publishing feedback from the field in ways which are relevant and useful to internal customers and corporate and site quality departments. Act as the Subject Matter Expert (SME) for PM during audits and regulatory inspections. Serves as Product Monitoring SME for successful execution of M&A projects, which includes Integration and Divestiture of business and/or products. Acts as liaison with IT as it applies to the platforms utilized by the PM department. Oversee and develop members of the PM team. Act as interface between PM, Pharmacovigilance, Medical Information and various departments. Establish and maintain positive and mutually rewarding relationships with external and internal customers.ESSENTIAL FUNCTIONS:
Responsible for the day to day functioning of PM relative to product complaint handling and related compliance activities.
Ensure compliance of PM with corporate level procedures for collecting, analyzing, trending, and reporting of post-market feedback reports.
Interact with manufacturing sites to facilitate consistent and timely complaint investigation and resolution.
Compose and maintain department SOPs as needed to assure compliance.
Responsible for the coordination of the HHE process which includes initiation, drafting, review and scheduling of HHEs.
Participate in execution and tracking of FAR and Recalls including oversight and tracking of product recall activities.
Coordinate and track departmental corrective actions (CAPAs) and exceptions (EXC).
Acts as the SME for PM during audits and regulatory inspections. Participate in the drafting of audit and inspection responses and assist in the coordination and completion of corrective actions related to audits and inspections.
Direct the collection of all data necessary to provide monthly product field performance reports.
Provide oversight of customer usage experiences, field feedback reports, product safety reporting, and professional consultation in matters related to safety, efficacy, and proper product functioning.
Prepare and deliver accurate reports of continuing product performance for Quality and other departments, conduct trend analyses in order to provide and alert to changing safety and efficacy profiles on regular and ad-hoc basis and identify potential product performance issues and alert appropriate management personnel when needed.
Provide expertise in process improvement initiatives such as Lean/Six Sigma projects.
Provide approval and oversight for handling of phone and other contact from internal and external customers. Interact with customers when management level assistance is required.
Provide functional requirements for databases and automation platforms supporting complaint and inquiry management. Review continuing performance of these platforms in light of changing external and internal requirements and translates these changes into IT upgrade or update requests. Provide continuing liason to IT functions to assure efficient, effective and adaptable product surveillance platform performance.
Involved in Business Development & Licensure activities as they pertain to Post-Market Surveillance data.
Involved with the execution of integration/divestiture of business and/or products as it relates to Post-Market Surveillance.
Identify, hire, train, develop and manage product surveillance specialists and production document coordinators.
Conduct Post Marketing Surveillance training as called upon to do so.
Interface with regulatory affairs, medical, quality, pharmacovigilance, commercial, S&T and legal; participate in, and provide product performance expertise on cross-functional project teams as necessary.
MINIMUM REQUIREMENTS:Education: Bachelor's degree in clinical or life sciences field.Experience: A minimum of 5 years clinical/practical experience in a relevant clinical environment or a minimum of 5 years in a similar pharmaceutical industry role. Thorough knowledge of FDA complaint reporting regulations and guidelines for pharmaceuticals and medical devices.Previous Regulatory Affairs, Quality Assurance experience in the pharmaceutical and/or medical device industry.Preferred Skills/Qualifications:1. Previous managerial experience (processes and people) preferred2. Knowledge of the clinical area, including products, procedures and the scientific and medical literature.3. Knowledge of FDA regulations and guidances in the area of complaint handling for pharmaceutical products and medical devices.4. Experience interacting with regulatory agencies such as the FDA.5. Writing skills necessary to effectively communicate technical/clinical information to others.6. Comfortable and capable of using software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.7. Certification in QA or RA discipline, or equivalent.Skills/Competencies:1. Writing skills necessary to effectively communicate technical/clinical information to others.2. Scientific literature searching and evaluation skills.4. Highly self-motivated5. Flexible6. Strategic thinker7. Sound organizational skills with the ability to prioritize tasks.8. Strong Presentation skills9. Ability to communicate information with courtesy and tact10. Superior verbal communication skills including impeccable telephone etiquette.Other Skills/Competencies:1. Initiative and mature judgement2. Accuracy and attention to detail and completeness of tasks3. Problem solving and analytical skills.4. Ability to effectively integrate customer and business needs in a satifactory manner.5. Ability to build productive relationships with personnel within and outside of the department and company.6. Ability to work effectively in multi-functional teams.ORGANIZATIONAL RELATIONSHIPS/SCOPE:
Reports to Executive Director, Quality
4 or more direct reports
Contact with regulatory authorities during inspections may be required.
Frequent communication and working relationships with manufacturing QA teams and operations.
Interact with a variety of departments. These include, but are not limited to, Legal Affairs, Regulatory Affairs, S&T, Medical Affairs, Quality Assurance, Commercial, and Customer Service. The degree and scope will vary according to the needs of the departments involved.
WORKING CONDITIONS:
Normal office conditions
Business casual attire
Occasional travel will be required for professional training seminars and conferences
Occasional travel, domestic and international, will be required for manufacturing site visits and off-site business meetings
DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
