Pharmacovigilance Specialist
2 weeks ago
Glaukos Corporation is seeking a highly skilled Pharmacovigilance Specialist to join our team in San Clemente, California. As a key member of our Pharmacovigilance department, you will be responsible for reviewing and processing adverse event information for spontaneous, solicited, literature, and phase IV study cases.
Key Responsibilities:
- 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.
What We Offer:
- Generous compensation and benefits package.
- Opportunities for professional growth and development.
- A dynamic and innovative work environment.
How to Apply:
Please submit your resume and cover letter to [insert contact information]. We are an equal opportunity employer and welcome applications from diverse candidates.
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