Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The company's drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. 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 has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 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 diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
- Performs medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines
- Accountable for seriousness, causality, and listedness assessments; medical accuracy and completeness of ICSRs; company comment; MedDRA coding
- Ensures that appropriate medical interpretation, consistency, and quality are applied to adverse eventcase assessment
- Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility
- Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs)
- Attends and presents at Investigator Meetings
- Performs review and clarification of trial-related Adverse Events (AEs)
- May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative
- May perform medical review of adverse event coding
- Performs review of the Clinical Study Report (CSR) and patient narratives
- Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
- Participates in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
- Work closely with Regulatory Affairs, and other senior leadership to ensure oversight of critical safety issues and benefit-risk assessments
- Participate in development and maintenance of risk management plans and REMS
- Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies
- Provides medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports
- Contribute to preparation of relevant regulatory documents and responses to regulatory inquiries
- Provides consultation for medically related questions from participating vendors, affiliates, etc.
- Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness
- Use in-depth knowledge of Pharmacovigilance science to provide expertise and insight to cross-functional colleagues as appropriate
- Development and execution of internal SOP for management of medical and product inquiries across Omeros products (marketed and pipeline)
- Development/update of standard response letters in collaboration with the medical director/s
- Monitoring and assessment of all medical and product inquiry for strategic and life cycle consideration
- Other relevant duties as assigned
What experience and education, skills and knowledge do you need?
- MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent)
- Minimum of 5 years of experience in Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting
- Excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
- Strong ability to understand and evaluate technical, scientific and medical information; exposure to clinical data collection, assessment, and analysis
- Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experiencepreferred; ability to learn new computer systems as they are implemented
- Working knowledge of global drug development and pharmacovigilance guidelines and regulations
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Excellent teamwork and collaboration; proficiency in verbal and written communication
- The ability to identify issues and take appropriate actions
- Excellent interpersonal skills, including the ability to work effectively cross culturally and cross functionally
- Ability to represent Omeros in a professional manner
- Some periods (e.g., high case volume) may require work days longer than 8 hours
- Work with international vendors may require being available outside of core working hours on occasion
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs.
- May encounter prolonged periods of sitting.