Valeant Pharmaceuticals

Manager, Global Device Complaints Management

Location US-NY-Rochester
Job ID
9947
Category
Quality
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

The primary focus of this position is to manage, train and motivate team members and to identify and lead the implementation of process improvements regarding complaint handling, medical device reporting and global complaint handling strategies.

In addition this position provides routine communication to supporting departments (global level) as well as senior management. This position also ensures that complaint handling and medical device reporting processes are compliant with domestic and international regulatory agency requirements.

 

The scope of this position is directly related to the global complaint management process and all processes related to complaint evaluations, complaint investigations and complaint trending. This position is indirectly related to quality systems, management review, corrective/preventive actions, customer service, regulatory affairs, medical/clinical affairs, sales and marketing as well as research and development. The position will include routine interaction and communication with internal business stakeholders and external business partners.

 

This position will supervise direct reports. 

Responsibilities

  • Provides daily leadership to team members concerning complaint handling activities, reportability assessments and submission of medical device event reports.
  • Generates, revises and implements robust and compliant complaint handling and medical device event reporting procedures.
  • Develops training materials and trains associates on procedures, policies, work instructions and guidelines.
  • Reviews adverse event reporting determinations to ensure they meet domestic and international regulatory requirements (FDA, MEDDEV, CMDCAS, ISO, etc.) prior to submission, when required.
  • Develops and implements complaint event tracking and trending data collection tools.
  • Provides data, trending and detailed analyses to support regulatory submissions.
  • Ensures complaint handling target metrics are met on a routine basis and escalates issues, when required.
  • Leads, develops and implements corrective and preventive actions to address complaint handling and medical device event reporting issues, as required.
  • Identifies and implements business process efficiencies to ensure timeliness metrics are consistently met.
  • Acts as Subject Matter Expert for complaint handling responsibilities.
  • Directly supports Regional Compliance audits, domestic and international regulatory agency inspections and Notified Body audits.
  • Communicates with internal and external medical professionals and/or consumers in order to determine the need to report the complaint event to regulatory agencies.
  • Completes documentation associated with personal performance reviews and communicates personnel reviews to team members.
  • Develops personnel goals and objectives.
  • Lead project activities and associated action items regarding on-going complaint handling improvements efforts.
  • Routinely interacts with Site Quality Assurance, External Manufacturing Quality Assurance, R&D, Customer Service and Medical Affairs in order to ensure robust complaint investigations are conducted.
  • Assesses critical complaint events and engages appropriate management, when required.

Key Relationships

 

Internal customers/business partners:

  • Medical Affairs
  • Customer Service
  • Regulatory Affairs
  • Research and Development
  • Design Quality Assurance
  • External Manufacturing Quality Assurance.
  • Manufacturing Site Quality Assurance
  • Legal
  • Sales and Marketing
  • Quality Systems/Compliance

 

External customers/business partners:

  • Physicians (including physician’s staff)
  • Consumers/Patients
  • Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

Qualifications

  • Bachelor of Science degree required.
  • Minimum 5 - 7 years related work experience within a medical device or pharmaceutical company required.
  • Minimum of 2 years experience in a senior lead or Supervisory role with direct oversight of personnel required

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

 

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