Description
Drug Safety Project ManagerThis role will suit you if:
- You have worked as a Senior PV Associate (2+ years)
- You have project management experience / training
- You have experience analysing metrics
- You have experience working in a CRO environment
- You have experience across all study phases, ideally early stage.
- Experience working in Pre-Clinical / Post-Marketing
- Extensive experience with SAE's
Responsibilities:
- Provide leadership and management of global and regional projects ensuring that communications and processes are harmonized for assigned projects.
- Monitor and manage the work flow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with International reporting regulations, Standard
- Operating Procedures (SOPs) and safety processing guidelines set forth by departmental management team.
- Responsible for making decisions regarding adverse event reporting within the guidelines of each assigned project.
- Work closely with the clinical operations and project management groups to ensure all safety activities are performed according to the regulatory and contractual requirements.
- Review of reporting of expedited safety reports and endpoints to clients, regulatory authorities, ethics committees and investigators within study specified timelines.
- Work on ARGUS database entry and performed independent QC of SAE reports in the database.
- Generation of ARGUS configuration database.
- Complete triage, distribution check list and quality review of all expedited safety reports for assigned projects.
- Provide independent QC of AE reports and SUSARs for other members of the group.
- Provide oversight and management of EudraVigilance activities and eSUSAR reporting for assigned projects.
- Moderate understanding of medical device reporting as per country specific requirements.
- Preparation of Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
- Monitor and manage project deliverables regarding contract assumptions; identify out of scope work or potential turn over budget.
- Generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
- Attend client meetings and liaise with clients where appropriate. Prepare and participate in audits, either by the client or regulatory agency.
- Prepare CAPA when there is a deviation from the accepted procedure.
- Assist in the development of departmental Work Instructions (WI) and Standard Operating Procedures (SOPs), as appropriate.
- Support/train less experienced safety staff in all aspects of case-handling, adverse event reporting and other work, as needed.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales