Pharmacovigilance Specialist

3 weeks ago

Boston, Massachusetts, United States Galderma Full time

Galderma is a leading dermatology company dedicated to advancing the field through innovative products and services. We are seeking a highly skilled Pharmacovigilance Specialist to join our team in Boston, MA.

Job Description

The Pharmacovigilance Specialist will be responsible for managing adverse event records, evaluating incoming communication, and providing medical evaluation of adverse events reports. This role requires a strong understanding of FDA guidelines and regulations, as well as excellent analytical and problem-solving skills.

Key Responsibilities
  • Evaluate incoming communication for potential adverse event reports and assess their seriousness.
  • Provide medical evaluation of adverse events reports and compile pharmacovigilance data.
  • Submit expedited reports to FDA and maintain a current working knowledge of company policies and procedures.
  • Support internal audits and external inspections, and maintain a current working knowledge of evolving local and international regulations.
  • Perform monthly reconciliation activities and maintain a local database of complaint contacts/case tracking & management.
  • Provide training to new employees on adverse event collection and reporting.
Requirements
  • Bachelor's degree in a healthcare or science discipline.
  • Healthcare education/certifications (i.e. RN, LVN, pharmacist) preferred.
  • Two to three years of professional experience in a healthcare setting, pharmaceutical company, or supporting clinical trials.
  • Working knowledge of FDA guidelines for post-marketing drug and medical device safety surveillance.
  • Excellent analytical and problem-solving skills, with the ability to prioritize and multitask under pressure.
What We Offer

Galderma is an equal opportunity employer dedicated to building an inclusive and diverse workforce. We offer a competitive wage, annual bonus opportunities, and career advancement and cross-training. If you are a motivated and detail-oriented individual with a passion for pharmacovigilance, we encourage you to apply for this exciting opportunity.

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