Pharmacovigilance Specialist
Galderma Laboratories

Job Info

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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 assesses incoming communication to identify potential adverse event reports. The Pharmacovigilance Specialist provides medical evaluation of adverse events reports, codes clinical trials adverse events, compiles pharmacovigilance data, and analyzes and submits expedited and periodic reports to FDA and Health Canada. The adverse event handling accountabilities reflect activities required to comply with local and international regulations, guidelines and applicable directives.

Job Responsibilities
50% - Evaluates incoming communication for potential adverse event reports via local intake system, phone, fax, mail and other methods.

• Medically evaluates adverse event reports for possibility of seriousness and expedited reporting to FDA and Health Canada
• Performs/coordinates follow up activities to obtain missing and additional information required for case processing
• Compiles, evaluates and submits serious and periodic reports to FDA and Health Canada.
• Ensures receipt of adverse events from Marketing programs and Social Media platforms
• Supports internal audits and external inspections
• Performs trending for adverse event reporting by preparing quarterly signaling reports

25% - Maintains a current working knowledge of:

• Company policies and procedures, departmental processes and associated work instructions
• Evolving local and international regulations, guidelines and applicable directives
• Galderma products (product inserts, DFUs, Promotional materials)
• Skin anatomy and skin common diseases

15% - Maintains and verifies local database of complaint contacts/case tracking & management

• Performs reconciliation with Medical Information, Product Quality and License partners

10% - Provides training to new employees about adverse event collection and reporting including training to call center vendor.

Other duties as assigned.

Minimum Requirements

• Bachelor's degree, preferably in healthcare or science discipline, is required
• Healthcare education/certifications (i.e. RN, LVN, pharmacist) preferred
• Five (5) or more years of professional experience in a healthcare setting, pharmaceutical company or supporting clinical trials, required
• Working knowledge of FDA and Health Canada guidelines for post-marketing drug and medical device safety surveillance
• Working knowledge of medical terminology, medical conditions, chemical structures/biological systems and drug products
• Familiar with relevant computer software such as ArigG or similar Drug Safety database
• Ability to prioritize and multi-task under pressure is required
• Proficiency in MS Office including Word, Excel, PowerPoint, and Outlook
• Good written and verbal communication skills
• Strong organizational skills
• Ability to work independently as well as with a team to accomplish tasks
• Minimal travel is required.

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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