Perfect role for someone with breadth of experience in post marketing safety management or PVG to work for a Pharmaceutical client for up to a year. This contract post is a maternity cover temporary contract on a competitive day rate.
Full JD available - the remit includes some ASR preparation so you must like analysis and collation/writing as well as handling complaints, and working in close collaboration with regulatory and medical information.
Great team , superb conditions and location apply now Ann has the details for you. She is looking form someone to start work in 4-6 weeks, the ideal person will met the following criteria:
Bachelor's degree in a science or healthcare related discipline.
Experience in a medical field (R.N., medical technician, pharmacy) is preferred.
Generally has 3+ years of drug safety experience
CRA or study coordinator experience is advantageous
Experience of safety databases and querying/report generation
Demonstrable understanding of Quality Management processes and compliance monitoring
Attention to detail in composing and proof-reading materials, establishing priorities, scheduling and meeting deadlines.
Excellent written and oral communication skills
Good medical writing skillsand ability to interpret and summarise aggregate data.
Requires experience of working with safety databases.
Working knowledge of MedDRA terminology and practices is necessary.
Good working knowledge of MS Word, Excel, PowerPoint and Outlook.
Requires good presentation skills
Must be able to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
Ability to work independently, take initiative and complete tasks to deadlines.
Must be able to effectively present complex information to management, CROs and the medical community.
Working knowledge of safety review process for IBs, protocols, informed consent and final study reports.
Ability to respond appropriately to^sensitive information and complaints.
Keywords:
ASR, PVG, safety, pharmacovigilance, MedDRA