Valeant Pharmaceuticals

Senior Manager, Global Device Compliant Management

US-NJ-Bridgewater
Job ID
9635
Category
Quality
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized 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 incumbent will be responsible for the overall management and leadership of the North American Device Complaints Management Teams responsible for the processing, evaluation and consistent handling of medical device complaints in accordance with all local laws and regulations.

The incumbent will lead the implementation of process improvements regarding complaint handling, medical device reporting and global complaint handling strategies.

Responsibilities

  • Provides daily leadership to teams concerning complaint handling activities, reportability assessments and submission of medical device event report's to Health Authorities.
  • Manage, train and motivate team leaders and/or members.
  • Generates, revises and implements robust and compliant complaint handling and medical device event reporting and other required standard operating procedures.
  • Develops training materials as required and ensures all team complete trainings on assigned procedures, policies, work instructions and guidelines.
  • Reviews adverse event reporting determinations to ensure they meet applicable regulatory reporting requirements 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 all complaint handling responsibilities.
  • Directly supports all Regional Compliance audits, domestic and international regulatory agency inspections and Notified Body audits
  • May communicate with internal 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.
  • Routinely interacts with 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.
  • Acts as designee for Director, Materiovigilance Operations when required.
  • Contributes to preparation of quality agreements, safety data exchange agreements and other inter-company service agreements and provides feedback in a timely manner.
  • May require up to 10% travel (domestic and international).
  • Position will be responsible for up to five (5) direct reports.
  • Support management review for quality system.
  • Contributes to materiovigilance intelligence activities.
  • Participation in activities related to safety issues: Corrective and Preventative Action (CAPA), Field Safety Correction Action (FSCA), cooperation with other company departments on Field Safety Notices.
  • Supervise direct reports 

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)
  • Patients
  • Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

Qualifications

  • Bachelor of Science degree in a technical discipline (Engineering, Biomedical, Life Science, etc.) is required.
  • Minimum 5 - 7 years related work experience in compliant management within a medical device or pharmaceutical company required.
  • Minimum of 2 years of experience in a senior lead or Supervisory role with direct oversight of personnel required.
  • Extensive/expert knowledge of reportability and vigilance regulations required.
  • Must have been directly involved in making reportability decisions and submitting medical device event reports.

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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