Product Complaint Manager I

Description

Duties & Responsibilities

• Conducts, maintains, and creates all product complaint and Adverse Event intake training, job aids, refresher slide decks and reference documents to ensure the contact center agents respond to and process technical product complaints and technical inquiries received by BIPI.
• Obtains all relevant information and creates complaint record within database.
• Understands complexity of complaints to interpret and propose proper classification and follow up.
• Notifies LPCO and appropriate partners for serious product quality issues.
• Approves and processes replacements, if applicable.
• Retrieves complaint product, processes and routes for investigation as outlined in relevant local and corporate SOPs and procedures.
• Reviews investigation reports within database and submits the complaint for final approval.
• Daily Monitoring the product complaint mailbox and performing daily review, evaluation, corrections on complaint records.
• Responds to, processes, and reviews technical product complaints associated with adverse events received by BIPI.
• Notifies the contact center of reported Product Complaint/Adverse Events received by TPI via mail or e-mail to ensure timely reporting to Pharmacovigilance (PSPV).
• Processes combined AE/PC cases in compliance with local procedures and regulations.
• Global Complaint database key user to ensure the proper handling of global requirements.
• Will support local or site requirements and assist in maintaining a streamlined approach to data entering to minimize local interruptions.
• Manages complaints and associated tasks, ensuring quality and timely completion despite challenges and volume associated with these items as well as manages changes in technology used to globally monitor and report complaints.
• Understands appropriate regulations; applies knowledge to ensure accurate and timely complaint handling.
• Assists in all documentation management on case handling, replacement, reimbursement processes for Product complaint and Adverse event links.
• Handles AE/PC reconciliation reports provided from and to Pharmacovigilance (PSPV).
• Provides support during internal/external audits and inspections under management supervision.
• Assists in other PC related activities such as reconciliation processes, metrics, reports, queries, etc. as directed by management and customers.
• Monitors product complaint mailbox daily and performs daily review, evaluation, corrections on complaint records.
• Resolves day-to-day inaccuracies and issues.
• Provides backup coverage for the other contact center day-to-day activities.
• Performs other contact center duties as assigned under management supervision.
• Contacts customers for follow-up information, troubleshooting, and device returns.
• Ensures that BI process and business operations comply with internal policies, processes as well as maintain compliance with Federal and or Health Care Compliance regulations.
• Ensures the accurate delivery of information to BIPI customers and safety for the patients they serve.

Requirements

• Bachelor´s degree required; preferably with one to two (1-2) years of relevant Quality Assurance experience, one to two (1-2) years of experience with product complaint intake, one to two (1-2) years of customer service or contact center experience or a minimum of three (3) years of pharmaceutical industry experience.
• Quality assurance knowledge of tools and methodologies.
• Customer service oriented.
• Experience working with all levels of management and an ability to influence without authority.
• Strong communication skills, both oral and written, as well as an ability to communicate complex issues in a simple way to resolve issues and mitigate risks.
• Ability to manage multiple projects in a very fast-paced environment.
• Strong organizational and priority skills.
• Excellent interpersonal skills; experience developing important relationships with key stakeholders, good conflict management and negotiation skills.
• Excellent analytical skills and proficiency in SharePoint, Excel, Work, Outlook, and PowerPoint.
• Ability to achieve the best utilization of resources of services, coordinate activities between two or more organizations, and responsible training, guidance documentation, etc. for all activities pertaining to technical product complaints.
• Ability to partner with medical information, contact centers and Quality HPS to continuously enhance business solutions through process improvements and efficiencies.
• Ability to apply product complaint (and adverse event / pc combination) knowledge to make sound judgment calls and driving continuous improvements.
• Ability to utilize required computerized systems with minimal supervision.

Compensation

This position offers a base salary typically between $65,000 and $138,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here.