Valeant Pharmaceuticals

GPSS Specialist

US-CA-Irvine
Job ID
9503
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 primary focus of this position is to perform all complaint handing related activities including submission of medical device event reports in accordance with domestic and international regulatory agency requirements.

 

Responsibilities


The scope of this position is directly related to complaint management and adverse event reporting responsibilities for all surgical products. The position will include interaction and communication with doctors and patients as well as internal business stakeholders.

  • Receives, documents and evaluates information regarding all domestic and international complaint events.
  • As required, communicates with physician, physician’s staff and/or patient to obtain pertinent event information.
  • Performs and documents reportability decisions on complaints in accordance with federal laws (US FDA) and international regulations (MEDDEV and Health Canada).
  • Communicates with local and international government regulatory agencies.  This includes generating and submitting medical device event reports as required by federal law and international regulatory agency regulations.
  • Participates in cross functional meetings (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D) to gather critical input in preparation for submissions and/or responses to local and international government regulatory agencies.
  • Responds to government agencies’ inquires associated with adverse event submissions (Serious Injury and/or Device Malfunction).
  • Reviews complaint investigation reports and ensures investigations are thorough and adequate and in accordance with procedures.
  • When required, supports root cause investigations and participates in CAPA (Corrective and Preventive Action) activities.
  • Generates responses to consumers and physicians based on complaint investigation results, when requested.
  • Participates in discussions with Legal, Marketing and Customer Service for concurrence prior to providing responses to complainant’s requests for information related to complaint events.
  • Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.
  • Compiles, reviews and closes complaint files.
  • Evaluates and engages appropriate management for critical and/or unusual events.
  • Supports complaint handling trending activities.
  • Generates complaint data reports for other departments, when requested.
  • As required, supports department projects and/or participates in cross functional projects.
  • Conducts weekly monitoring duty per departmental procedures.
  • Generates periodic reports as requested per government agencies and/or Notified Bodies.
  • Performs all other duties as assigned.

 

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

 

External customers/business partners:

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

Qualifications

  • Bachelor‘s degree in scientific or business related discipline required (Biomedical, Arts, Engineering, Science, etc.).
  • Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance Reporting regulations, GMPs for medical devices preferred.
  • Position requires strong written, oral and listening communication skills in order to interact with customer and other professionals.
  • Must be able to generate and organize clear, concise responses when communicating with various levels of management.
  • Superior organizational skills to be able to manage challenging deadlines.
  • Adjusts to change with minimum or no interruption.
  • Recognizes problems and suggests applicable solutions.
  • Able to perform job function with minor supervision and make independent decisions, where appropriate.
  • Proficient in the use of personal computers, including database management, trending and word processing.
  • Understanding of 21 CFR 820/803 and ISO 13485 requirements required.
  • Minimum of 3-5 years related work experience is 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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed