Zest Scientific has been instructed to identify a talented pharmacovigilance professional for global organisation. We are looking to hear from drug safety and PV professionals with extensive experience of overseeing PV quality and management of Individual Case Safety Reporting.
- With a broad safety background and experience, you will have strong safety knowledge
- With broad and comprehensive expertise within the Safety environment you will lead project work and partner with the business to solve complex safety issues that impact the wider business.
- Contributes to development of strategic plans and goals.
- Actively contributes to the learning & development of other team members.
- A scientific degree is required.
- Having oversight of AE reports being processed accurately and within required deadlines, ensuring that all reportable cases are submitted to the MHRA in compliance with their timelines
- Maximising the quality of information captured relating to ICSRs and ensuring that this is recorded accurately and in a timely manner and in accordance with global and local SOPs and related documents
- Ensuring that the appropriate method of follow up is used to obtain additional information from reporters when appropriate and ensuring that any issues/queries related to AE reports are resolved in collaboration with internal and external stakeholders
- Timely completion of coordination and support tasks including QC of the data entry and submission of ICSRs and workflow manager responsibilities
- Reviewing the quality of activities outsourced to UK-TCS and ensuring that this quality is maintained to a high standard
- Acting as a PV approver for MAPs, including the setup, maintenance, training and closeout of these programmes
- Reviewing clinical trial documentation and publications to ensure PV compliance and performing the analysis of safety data originating from locally managed studies/programmes
- Write and review safety reports and safety regulatory documentation and review safety data outputs for local signal detection
- Awareness of the Risk Management Plans (RMPs) and associated pharmacovigilance requirements. Acting as the RMP-IC back as required
- Oversight of reconciliation activities to ensure that they are completed accurately and on time
- Quality checks and oversight processes are created and maintained to ensure UK DSC compliance with internal and regulatory timelines, is responsible for the escalation of issues
- Ensuring that all queries, including the team inboxes, are assigned and actioned appropriately and in a timely manner
- Performing other PV and product safety related tasks as needed, or supports UK DSC team members in PV activities related to study and program oversight, management of aggregate reports, local PV agreements, safety communication, PV quality, service provider oversight and monitoring
- Acting as a local process owner/subject matter expert (SME), driving process improvements and oversight responsibilities within these areas. This includes the formulation of KPIs/metrics to track oversight within this area, making key decisions within this area; acts as SME during regulatory authority inspections and internal audits and a CSF (Clinical and Safety Finding) implementation responsible when assigned
- Organising, facilitating and providing training to internal and external stakeholders on safety-related processes and activities along with adverse event (AE) reporting requirements.
- Actively partnering with the business in providing PV and product safety expertise and representation for new and ongoing activities which includes but is not limited to, Non-Interventional Studies (NIS), Interventional Clinical Trials (ICT), digital activities and activities requiring the spontaneous PV clause; support in the assessment of PV related activities and ensuring that the correct process is followed based on the classification
Our client is a rapidly expanding organisation at the forefront of expert research. They are actively looking to recruit the best from within the drug safety and pharmacovigilance space, so if you are a pharmacovigilance and drug safety professional looking to develop your career with a progressive organisation, this role could be for you.
Our client is committed to securing the services of the right candidate and is flexible with regards to the remuneration package available. Zest Scientific is working to a strict deadline so in order to be considered for this opportunity please apply now and your application will be reviewed immediately.
Contact: Neil Dewsbury
Telephone: 0114 238 1728