Pharmacovigilance Specialist
2 weeks ago
This role requires an individual who will be 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.
- Responsible for global pharmacovigilance review of ICSRs in safety databases for completeness, accuracy, and regulatory reportability.
- Filing of safety-related documents and ICSRs.
- Review adverse event data from product complaints, inquiries, and literatures and assess for regulatory reporting requirements.
- Identify information to be queried and follow up with PV vendors/Medical safety until information is obtained and queries are satisfactorily resolved.
- Collaborate with cross-functional development functions - Medical, Clinical Operations, Data Management, Biostatistics, Regulatory, etc.
- Assist pharmacovigilance department in safety and risk management activities and other relevant safety projects or duties as assigned/needed.
- Ensure that all safety reporting requirements of the FDA and other regulatory agencies are met.
- 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.
Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol 'GKOS'.
Our global headquarters is in Aliso Viejo, California, with additional locations in San Clemente, California, and Burlington, Massachusetts.
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