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Sr. Manager/Associate Director, Pharmacovigilance

Company: Omeros Corporation
Location: Seattle
Posted on: June 15, 2019

Job Description:

Good things are happening at Omeros!Manage and oversee 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 proceduresWho is Omeros?Omeros is a-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 intraocular solution) 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 platformResponsibilities:Post-marketing pharmacovigilance

  • Responsible for day to day activities of the pharmacovigilance team, managing resources, workload quality and metrics and updating senior management of projects' progress
    • Responsible for uniform processing of marketed product individual case safety report assessment, meeting reporting timelines, and quality compliance
      • Develops department pharmacovigilance operation processes and standard operating procedures
        • Interacts with and has oversight of internal and external global pharmacovigilance collaborators to ensure maintenance of regulatory pharmacovigilance compliance
          • Has primary responsibility for periodic safety reports for marketed products (PADER, PSUR, PBRER) and development reports (DSUR) of marketed products that are under further clinical development
            • Develops safety data exchange agreements
              • Develops safety sections of contractual agreements with distributors and partners
                • Responsible for marketed product signal management
                  • PV representative on the company's Product Safety Committee
                    • Oversight of product's labeling and Reference Safety Information
                      • Contribute to assessing risks in the context of product's benefits in collaboration with other functions' subject matter experts Clinical development pharmacovigilance
                        • Interacts with clinical development department for processing individual case safety reports from clinical trials
                          • Provide development support for clinical plans, individual study protocols and safety risk management
                            • Assist in writing Investigator Brochures, DSURs and other regulatory documents
                              • Ensure that all relevant clinical safety data are collected in a timely manner and assist in cleaning of data listings
                                • Review scientific literature
                                  • PharmD, R.N., Nurse Practitioner or PhD required with at least 3 (three) years of related experience and/or training; or an equivalent combination of education and experience in regulatory affairs/pharmacovigilance
                                    • Prior experience in CRO or Pharma/Biotech safety function required
                                      • Strong working knowledge of drug development and pharmacovigilance guidelines and FDA/EMA regulations
                                        • Minimum of 1 year of medical writing experience (preferably in reports such as DSURs, PSURs, CSRs, CTD)
                                          • Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
                                            • Excellent oral and writing communication skills including the ability to write routine reports and correspondence
                                              • Strong computer application skills used in general office settings including word processing, spreadsheet, presentation software, and Internet search engines
                                                • Excellent teamwork and collaboration
                                                  • The ability to build and maintain positive relationships with management, peers, and subordinates
                                                    • Good interpersonal skills with the ability to represent regulatory affairs in a positive and professional manner
                                                      • Good organizational and planning skills
                                                        • The ability to identify issues and take appropriate actions
                                                          • Must display strong analytical and problem-solving skills
                                                            • Attention to detail
                                                              • Must represent Omeros in a professional manner
                                                                • The employee is occasionally required to travel overnight
                                                                  • May encounter prolonged periods of sitting
                                                                    • The employee may frequently be performing repetitive movements such as typing on a keypad or using a computer mouse
                                                                      • The employee may climb, bend, reach, push, pull, balance, stoop, kneel, or crouch
                                                                        • The employee, on occasion, must lift and/or move up to 20 pounds 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 or contact Omeros, asking for Human Resources, at .

Keywords: Omeros Corporation, Seattle , Sr. Manager/Associate Director, Pharmacovigilance, Executive , Seattle, Washington

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