As a member of the Regulatory Affairs team, you’ll be responsible for managing and overseeing global drug safety/pharmacovigilance processes including the collection, safety review, processing, and reporting of adverse event data in compliance with applicable FDA, EMA, regional, and/or country regulations and Omeros standard operating procedures.
Good things are happening at Omeros!
Come join our Regulatory Affairs Group!
Who is Omeros?
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.
Part of its proprietary PharmacoSurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.
What are your job responsibilities?
Uniform processing of marketed product individual case safety report assessment, meeting reporting timelines and quality compliance
Interacting with and having oversight of internal and external global pharmacovigilance collaborators, you’ll ensure maintenance of regulatory pharmacovigilance compliance
Primary responsibility for periodic safety reports for marketed products (PADER, PSUR, PBRER) and development products (DSUR)
Developing safety data exchange agreements
Marketed product signal management
PV representative on the Company’s Product Safety Committee
Developing department pharmacovigilance operation processes to meet regulatory reporting requirements
Managing regulatory tasks within time and budget of approved project plans
What experience and education do you need?
You’ll need to have a BS degree, preferably in a related field and a minimum of 5 years of related experience and/or training or an equivalent combination of education and experience in regulatory affairs/pharmacovigilance.
Additionally, we are seeking candidates with the following experience:
3+ years of experience in the pharmaceutical industry with a minimum of 1 year in CMC regulatory
What skills does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
A strong working knowledge of drug development and pharmacovigilance guidelines and FDA/EMA regulations
Detail orientation, organizational skills and the ability to prioritize multiple tasks to meet deadlines
Demonstrated verbal and written communication skills including the ability to write routine reports and correspondence
Strong computer application skills used in general office settings including word processing, spreadsheets, presentation software, and internet search engines
Decision making skills
Analytical and problem solving skills with the ability to constructively analyze problems, identify issues and take appropriate action
Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates.
What else do you need to know?
Occasionally, you’ll be required to travel overnight
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
All interested applicants should apply at: Omeros.com, About Omeros, Careers. This will route you to our online applicant tracking system.
Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.
It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000.
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.
Derived from its proprietary PharmacoSurgery® platform, the company’s first drug product, Omidria® (phenylephrin...e and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission (EC) has approved Omidria for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington’s disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic surgical procedures. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.