Safety and Benefit Risk Associate
A well-respected biotechnology company is looking for a SABR Associate to join their talented team in Maidenhead. This company is dedicated to the development, and delivery of therapies for the treatment of neurological diseases to patients worldwide.
- Collection and timely reporting of all adverse events/safety reports to GSRS or external provider as defined both by internal SOPs and UK and Irish regulations
- Assisting in Audit & Inspection readiness as required and assisting with audits/monitoring visits of external third-party vendors
- Maintenance of local PV processes and 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 conten
- Maintaining oversight of outsourced vendors with PV responsibilities
- Tracking safety data exchange agreements
- Responsible for PV oversight for Company's patient support programs and homecare
- Assisting GSRS with late case investigations
Skills and Requirement
- Primary life sciences degree/qualification
- Minimum of 3 years of industry PV industry experience
- Knowledge of local regulations
- High attention to detail
- 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
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Divya Mistry at (+1) 646-630-9650 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.