Job Description
Pharmacovigilance Specialist - Onsite/hybrid
How you will make an impact:
This role requires an individual who will be processing 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.
This position will be based in San Clemente, California. This individual is responsible for Post Market and Clinical trial PV Case Processing. This role requires an individual who can perform at a high level in a fast-paced environment and prior safety-related expertise, with an ability to understand and comply with general pharmaceutical industry rules, regulations, and company processes.
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What will you do?
- Perform tasks and duties in compliance with appropriate SOP, policies, and procedures
- Responsible for Global Pharmacovigilance review of ICSRs in safety database 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.
- Identifies information to be queried and follows up with PV vendor/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.
- Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
- 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.
- This role works onsite M-W-F - hybrid
#GKOSUS
About Us
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, 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 constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
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.
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.