accurate audits and monitor visits of external vendors? If that's the case, this role is for you!
This is a 6 month contract working for a pharmaceutical business in the Maidenhead area. The client is looking for an experienced Drug Safety Associate to work on the UK and Ireland account be involved in the PV processes and procedures that take place.
If you are a Drug Safety Associate and looking for a new challenge then please apply!
Main Duties: * Responsible for the overall provision of safety report handling relating to BI UKI * Maintenance of local PV processes and procedures * Training and tracking of all external providers on appropriate PV-related procedures * Ensuring awareness of any programmes/contractual arrangements with external providers with significance for handling AE information according to relevant procedures * Review of external provider reports for AEs and PCs * Tracking of safety reports from a variety of sources within specified timelines * Reviewing and tracking local literature for safety-related content * Maintaining oversight of outsourced vendors with PV responsibilities * Assisting GSRS with regulatory requests or audits/inspections * Assisting with monthly reports on PV metrics * Assisting with PV Operations Vendor's compliance and follow-up activities * Tracking safety data exchange agreements * Responsible for PV oversight for Company's patient support programs and homecare * Assisting GSRS with late case investigations * Overseeing PV-related CAPA/Exception management GSRS/IPV
Experience and Requirements: * Minimum of 3 years of industry PV industry experience * Knowledge of local regulations * High attention to detail * Ability to work independently on routine and new assignments * Good experience of working in an affiliate environment * Experience of working with homecare companies and patient support programs * Process driven with ability to set work systems, procedures and track performance * Understanding of commercial business needs and strategy * Significant experience of ICSR processing and quality checking
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business
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