Valeant Pharmaceuticals

Global Product Surveillance and Safety Supervisor

Job Location US-MO-St Louis
Job ID
9945
Pos. Category
Quality

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 responsibility of this position is to lead, train and motivate team members in all aspects associated with the global complaint management process. This includes leading the global reporting obligations and the management of communications between manufacturer, distributors and competent authorities for all medical device complaint related activities, including assistance of and/or submission of medical device event reports in accordance with applicable local laws and regulations.

 

The scope of this position is directly related to the complaint management and medical device event reporting responsibilities for medical device products.

 

This position will include interaction and communication with doctors and patients as well as internal business stakeholders.

 

This position reports to the Manager Global Device Complaint Management.

 

This position will supervise direct reports. 

Responsibilities

  • Supports manager GDCM concerning routine complaint handling activities, adverse event reportability assessments and submission of medical device event reports.
  • Receives, evaluates, and processes information for complaints.
  • Provides guidance to team members regarding medical device event reporting requirements as per the applicable local laws and guidelines.
  • Generates and submits medical device event reports to regulatory agencies, when required.
  • Acts as Subject Matter Expert for all complaint handling and medical device event reportability responsibilities.
  • Communicates with medical professional are/or consumers to clarify or obtain additional information to investigate complaints.
  • Completes documentation associated with personnel performance reviews and communicates personnel reviews to team members.
  • Generates and/or revises standard operation procedures, forms and work instructions.
  • Identifies opportunities to improve complaint handling and medical device event reporting processes.
  • Develops and implements corrective and preventive actions to address complaint handling and medical device event reporting issues, as required.
  • Directly supports Compliance audits, external regulatory agency inspections and Notified Body audits.
  • Assists manager GDCM with developing personnel goals and objectives.
  • Assesses, elevates and engages appropriate senior management for critical and/or unusual complaint events.
  • Generates periodic reports as requested per government agencies and/or Notified Bodies.
  • Position may be responsible for supervising up to six (6) FTEs as well as supervising temporary contract personnel.
  • 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 (Engineering, Life Science, etc.)
  • Extensive knowledge and demonstrated experience regarding medical device event reporting requirements.
  • Direct experience with making reportability decisions and submitting medical device event reports.
  • Strong ability to mentor/motivate staff and lead by example is required.
  • Knowledge of GMPs, QSRs and ISO regulations is required.
  • Knowledge and experience with ophthalmic medical terms and eye disease is desired but not required.
  • Strong written and oral communication skills are required.
  • Experience with complaint management and medical device event reporting databases is required.
  • Minimum of 5 - 7 years related work experience within a medical device or pharmaceutical company 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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