Drug Safety Coordinator
Onyx Pharmaceuticals, Inc. - South San Francisco, CA

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The Drug Safety Coordinator encompasses a key role in the day-to-day functioning of the Pharmacovigilance and Drug Safety department. Responsible adverse event report receipt, triage and distribution for assigned investigational and marketed products, while maintaining compliance with Onyx SOPs and FDA, ICH and worldwide regulations to ensure uniform and timely processing and reporting of adverse event reports. Works in close collaboration with colleagues from Clinical Operations, Biometrics, Regulatory & QA, and Clinical Science. Adverse Event Case Management Responsibilities: Triage all domestic and foreign incoming safety reports received by Onyx (clinical trial and post-marketing), appropriately scheduling case reports in Onyx safety database based on the following criteria: source, seriousness, data entry priority, initial vs.

follow-up report.Enter appropriate case data into the Onyx safety database in a timely manner, utilizing management-determined data entry guidelines.Assist with gathering the required follow-up information for assigned cases.Create and maintain electronic and hard copy case files as per Onyx SOPs and guidelines.Distribute individual case safety reports to CROs, participating clinical trial investigators, partner companies, and other trading partners, as needed, to ensure compliance with regulatory and company timelines.Additional Safety Management Responsibilities: Assist in the generation and distribution of safety line listing reports, summary tabulations, and/or metric reports for company management, partner companies, and collaborative sponsors, as needed.Assist in the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems.Other duties as assignedDepartmental and Line Management Responsibilities: Collaborate with department personnel to identify Drug Safety process needs and areas for improvement.Assist with the maintenance of the ARISg safety database, including participation in validation and implementation activities for system upgrades and maintenance of the safety database user manual.Contact departmental Management immediately if a regulatory agency has requested an inspection, or if there are any serious compliance observations within the Drug Safety department.Requirements Work Experience: Previous pharmaceutical, research or clinical experience a plus. Functional/Technical Knowledge & Skills: Strong computer skills (MS Office)Experience with software-based drug safety systems a plus, preferably ARISgFamiliarity with relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments is a plus.Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus.Education/Training: Associates or Bachelor’s degree in life sciences, pharmacy or nursing or equivalent.Other Requirements: Strong communication skills (verbal and written).Strong interpersonal skills and professionalismAbility to work independently, as well as within a team environment.Focus on detail with enthusiasm to constantly seek ways to improve processes and practice.Ability to work in a dynamic environment and manage competing prioritiesCompetencies: Action Oriented – Enjoys working hard; is action oriented and full of energy for the things he/she sees as challenging.Time Management – uses his/her time effectively and efficiently; concentrates his/her efforts on the more important priorities.Timely Decision Making – makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure.Decision Quality – Makes good decisions based on a mixture of analysis, wisdom, experience, and judgment.

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Onyx Pharmaceuticals, Inc. (Onyx) is a biopharmaceutical company engaged in developing therapies that target the molecular mechanisms that...