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The Drug Safety Associate reports to and takes direction from the Head of Drug Safety.
Essential Duties And Responsibilities
• Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
• Argus system admin
• Provide oversight of PV Safety operations and or designated CROs and Vendors, as assigned by the Head of Pharmacovigilance.
• Perform Quality Check (QC) review of SAEs reports.
• Responsible and oversight for PV inspection readiness activities and quality in collaboration to Quality Assurance.
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements and timelines.
• Assist designated safety vendors with opinion on obtaining follow-up information for individual cases and ensuring appropriate feedback from Global Clinical and Safety Leads.
• Interface with other functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Quality, business units, as needed.
• Contribute to on-going process enhancement for safety operations such as developing standard procedures and templates.
• Organize, manage and actively carry out PV activities, such as adverse event monitoring, safety reporting, risk management, safety monitoring activities, inspection preparedness
• Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
• Ensure complete and timely forwarding of ICSRs
• Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed
• Assist in the reconciliation of clinical and safety databases
PRIVATE AND CONFIDENTIAL
• Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment reports.
Required Education and/or Experience
• RN / Pharmacist experience.
• 5+ years of experience in a similar role.
• ARGUS Experience and understanding
• Hematology/Oncology experience (highly desired but not required).
• Experience in relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing CS reporting in the conduct/processes of clinical trials and PV.
• Working knowledge of medical terminology and principles of clinical assessment of AEs/SAEs in the pharmaceutical/biotechnology industry.
• No direct reports.
• Sound medical judgment and decision-making capabilities.
• Ability to review and interpret lab test results for clinical significance.
• Detail-oriented with excellent planning, organization and time-management skills including the ability to support and prioritize multiple projects in a proactive manner.
• Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Expertise in the use of Electronic Document Management System (eDMS) software.
• Expertise in World Health Organization's Drug Dictionary (WHODD) with relevance to coding suspect drug and concomitant medications.
• Ability to identify and raise issues early and find solutions.
• Excellent interpersonal and written/verbal communications skills.
• Ability to build strong relationships with a wide variety of internal (e.g. senior management) and external stakeholders.
• Excellent leadership and supervisory skills.
• Can influence people without a direct reporting relationship.
• Any experience with regional, national and global regulatory authority is a plus.
• Computer proficiency with the MS Office Suite (e.g. Excel, Word, and PowerPoint).
• Ability to travel as needed; approximately 10%.
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