Pharmacovigilance Specialist
Galderma Laboratories

Company Overview
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

Job Description
The Pharmacovigilance Specialist is responsible for day-to-day case management of adverse event records. This position will assess incoming communication to identify potential adverse event reports and Provide medical evaluation of adverse events reports. This role is responsible for handling adverse event accountabilities in order to comply with local and international regulations, guidelines and applicable directives.

Job Responsibilities

• 60% - Evaluates incoming communication for potential adverse event reports via local intake system, phone, fax, mail, social media and other methods in the Wilke database.
  • Medically evaluates and processes adverse event reports daily from the Wilke database for possibility of seriousness and expedited reporting to FDA and Health Canada. Reports cases to the proper regulatory authority within the required reporting period, as needed.
  • Processes daily queries from Galderma Global case processing team and provides response within the same business day.
  • Processes literature cases as needed and maintains literature report spreadsheet.
  • Provides Pregnancy Case follow up and maintains report spreadsheet.
  • Ensures receipt of adverse events from Marketing programs.
  • Supports internal audits and external inspections.
  • Performs trending for adverse event reporting by preparing quarterly reports.
  • Prepares Annual Summary report for drug products marketed in Canada.
  • Performs reconciliations for Product Quality complaints and reports involving partners.
  • Conducts monthly Health Canada Adverse event search in the Vigilance database.
• 25% - Provides training to new employees about adverse event collection and reporting including training to call center vendor.
  • Leads weekly and sometimes daily calls/emails with the call center to provide feedback on case processing corrective actions to be taken.
• 15% - Maintains a working knowledge of:
  • Company policies and procedures, departmental processes and associated work instructions.
  • Evolving local and international regulations, guidelines and applicable directives.
  • Alchemee products
  • Maintains knowledge of skin anatomy and skin diseases
  • Updates SOP's and work instructions as needed.

Other duties as assigned

Other Important Information
Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

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