Sr. Manager/Associate Director, Pharmacovigilance Operations

Sr Manager/Associate Director, Pharmacovigilance Operations
Manage and oversee global drug safety/pharmacovigilance operational 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. This will be required for both clinical development and post-marketing pharmacovigilance.
Good things are happening at Omeros!
Come join our Reg Affairs & Quality Systems Omeros Team!
Who is Omeros?
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com .
What are your job responsibilities:
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 and approval, meeting reporting timelines, and quality compliance via oversight of CROs and Vendors responsible for outsourced Pharmacovigilance responsibilities and tasks
• Interacts with and has oversight of internal and external global pharmacovigilance collaborators to ensure maintenance of regulatory pharmacovigilance compliance
• Provide safety information and required listings 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 assisting PV staff with marketed product signal management
• PV representative on the company's Product Safety Committee
• Assist in the development and review of product's labeling and Reference Safety Information
• Develop a strong partnership with the QPPV to support PSMF activities and any other related requirements.
• Contribute to assessing risks in the context of product's benefits in collaboration with other functions' subject matter experts

Clinical development Pharmacovigilance

• Responsible for uniform processing of investigational product individual case safety report assessment and approval, meeting reporting timelines, and quality compliance via oversight of CROs and Vendors responsible for outsourced Pharmacovigilance responsibilities and tasks
• Interacts with clinical development department for queries related to processing individual case safety reports from clinical trials
• Provide development support for safety sections of clinical plans, individual study protocols and safety risk management
• Provide support and assist in writing Investigator Brochures, DSURs and other regulatory documents
• Attend all Clinical Trial team meetings for initiated and on-going clinical trials; Safety Operations representative/member of all cross-functional team meetings
• Ensure that all relevant clinical safety data are collected in a timely manner and assist in cleaning of data listings, including support for data reconciliation
• Collaborate with the QPPV for requirements in the EU for clinical trials and access to EU safety reporting portals
• Support clinical development in the review and completion of the safety section of the eTMF for clinical trials

General Responsibilities

• Develop Oversight Plans for CROs and Vendors responsible for any clinical development and post-marketing outsourced processes and tasks
• Review and approval of all SUSARs to be submitted to all regulatory authorities, including FDA and requirements for Rest of World (ROW) for all investigational and marketed products, including distribution for any EAP/CU programs
• Develops department pharmacovigilance operation processes and standard operating procedures
• Development and maintenance of the Pharmacovigilance SharePoint site
• Assist the Quality Assurance Department in developing Quality Plans for CROs and Vendors and preparing/conducting safety audits for compliance in Pharmacovigilance
• Ensure the collection of scientific literature required for periodic reports from Vendors and CROs responsible for clinical development and post-marketing PV activities

Education, Skills and Knowledge Required:

• PharmD, R.N., Nurse Practitioner, PhD or Advanced Scientific Discipline required with at least 3 (three) to 5 (Five) years of related experience and/or training; or an equivalent combination of education and experience in pharmacovigilance
• Prior experience in oversight of CRO or Pharma/Biotech safety functions required
• Strong working knowledge of drug development and pharmacovigilance guidelines and FDA/EMA regulations
• Experience in writing Pharmacovigilance sections of relevant documents (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
• Good interpersonal skills with the ability to represent Omeros pharmacovigilance in a positive and professional manner
• Strong computer application skills used in general office settings including word processing, spreadsheet, presentation software, and Internet search engines
• Excellent teamwork and collaboration
• Good organizational and planning skills
• Must display strong analytical and problem-solving skills
• Attention to detail

Behavioral Competencies Required:

• The ability to build and maintain positive relationships with all levels of management, peers, key stakeholders, and subordinates
• Ability to shift frequently among projects as needed to support changing priorities and multiple projects
• Experience and enthusiasm for working within a small organization with limited resources and ability to be flexible, contributory where needed, "wears many hats"
• Strong ability to educate, establish and communicate expectations on the scope and timing of work to be performed.
• The ability to identify issues and take appropriate actions
• Must represent Omeros in a professional manner

Other Requirements:

• The employee is occasionally required to travel overnight

Physical Demands Required:

• 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

Compensation and Benefits:
Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Sr Manager position is $160,000 to $200,000 per year. And the Associate Director is $175,000 to $205,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision and life insurance and a 401k plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for bonus and stock options. To learn more about Omeros, please visitwww.omeros.com.
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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000