Pharmacovigilance Specialist

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Job Title: Pharmacovigilance Specialist

Location: Boston, MA (Hybrid 3 days in office)

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, compiles pharmacovigilance data, and analyzes and submits expedited to FDA. The adverse event handling accountabilities reflect activities required to comply with local and international regulations, guidelines and applicable directives.

Key Responsibilities

• 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
• 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.
• Ensures receipt of adverse events from marketing programs, license partners and social media platforms
• Performs monthly reconciliation activities
• Supports internal audits and external inspections
• 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)
  • Maintains and verifies local database of complaint contacts/case tracking & management
  • Performs reconciliation with Medical Information, Product Quality and License partner
• Provides training to new employees about adverse event collection and reporting including training to call center vendor.
• Other duties as assigned.

Skills & Qualifications

• Bachelor's degree, preferably in healthcare or science discipline, is required
• Healthcare education/certifications (i.e. RN, LVN, pharmacist) preferred
• Two (2) to Three(3) or more years of professional experience in a healthcare setting, pharmaceutical company or supporting clinical trials, required
• Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance
• Working knowledge of medical terminology, medical conditions, chemical structures/biological systems and drug products x Familiar with relevant computer software such as ARGUS or similar Drug Safety database
• Ability to prioritize, problem solve, think critically 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 x Ability to work independently as well as with a team to accomplish tasks
• Boston Hybrid Role - 3 days/week in office

What we offer in return

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.

Next Steps

• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employer's Rights:

Galderma is an equal opportunity employer dedicated to building an inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, genetic information, or any other characteristic protected by applicable law. Galderma is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment.

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