Product Complaint Manager I (Hybrid)

$65,000 - $138,000/Yr

Boehringer Ingelheim International - Danbury, CT

Full-time - Entry Level

Danbury, CT

Merchant Wholesalers, Nondurable Goods

About the position

The Product Complaint Manager I is responsible for overseeing the product complaint and adverse events intake process, ensuring compliance and quality in handling product complaints. This role involves training, documentation, and collaboration with various departments to facilitate effective complaint management and support product launches. The manager acts as a Subject Matter Expert (SME) in product complaints, providing guidance and driving improvements in processes.

Responsibilities

• Conducts, maintains, and creates all product complaint and Adverse Event intake training, job aids, refresher slide decks and reference documents.
• 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 of 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.
• Acts as a global Complaint database key user to ensure proper handling of global requirements.
• Manages complaints and associated tasks, ensuring quality and timely completion despite challenges and volume.
• 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.
• 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.

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 simply.
• 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.

Nice-to-haves

• Experience in the pharmaceutical industry.
• Familiarity with regulatory compliance in product complaints.

Benefits

• Competitive compensation and benefit programs.
• Opportunities for professional development and training.
• Support for work-life balance and employee well-being.