Valeant Pharmaceuticals

Sr. Product Surveillance Specialist

US-MO-St Louis
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. In addition this
position supports training activities related to the complaint management
process.

Responsibilities

  • Receives, reviews and assesses complaint event information related to domestic and international complaints.
  • 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.
  • Coordinates and facilitates 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.
  • Regularly interacts with internal Medical Affairs staff to obtain approvals of all communications with 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.
  • Identifies potential process improvements regarding the complaint handling and medical device event reporting processes.
  • Evaluates and engages appropriate management for critical and/or unusual events.
  • Generates and/or revises complaint management procedures, forms and work instructions, when required.
  • Performs complaint handling and adverse event report trending.
  • Provides complaint data to Regulatory Affairs and Medical Affairs necessary for device approvals and/or certifications.
  • Generates complaint data reports for other departments, when requested.
  • As required, leads 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.

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.
  • Candidate 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 identifies appropriate solutions.
  • Able to perform duties without supervision and make independent decisions.
  • Candidate must be proficient in the use of personal computer, including database management, trending and word processing. 
  • Demonstrated knowldge of 21 CFR 820/803 and ISO 13485 requirements required. 
  • Minimum of 5-7 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.

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