Pharmacovigilance Specialist

2 weeks ago


San Clemente, California, United States Glaukos Corporation Full time
Job Title: Pharmacovigilance Specialist

Glaukos Corporation is seeking a highly skilled Pharmacovigilance Specialist to join our team.

About the Role:

This is a unique opportunity to work in a fast-paced environment and utilize your expertise in pharmacovigilance to ensure compliance with pharmaceutical and medical device regulations.

Key Responsibilities:
  • Process adverse event information for spontaneous, solicited, literature, and phase IV study cases.
  • Perform drug safety activities to ensure compliance with pharmaceutical and medical device regulations.
  • Review adverse event data from product complaints, inquiries, and literatures and assess for regulatory reporting requirements.
  • Collaborate with cross-functional development functions, including Medical, Clinical Operations, Data Management, Biostatistics, Regulatory, and others.
  • Assist the Pharmacovigilance department in safety and risk management activities and other relevant safety projects or duties as assigned.
Requirements:
  • Bachelor's Degree in a Life Sciences discipline required; Graduate degree and/or post-doctoral training preferred.
  • Minimum of 3 to 5 years of direct experience in a drug safety/pharmacovigilance environment within the pharmaceutical industry required.
  • Safety Database systems and knowledge of medical terminology required.
  • Good understanding of Post-marketing safety requirements for device/combination products.
  • Knowledge of FDA, ICH, and GCP regulations.
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail.
  • Strong technical and analytical skills to identify and solve problems.
  • Good organizational skills with proven ability to prioritize projects.
  • Excellent written and oral communication skills.
Work Environment:

This role works onsite M-W-F - hybrid.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.



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