Multinational Pharmaceutical company are looking for 2 Safety System Aggregate Reporting Consultant to join a large team of safety consultants for an initial 6-month contract.
You must be highly proficient in Health Authority / country-specific requirements for Patient Safety reporting at an individual case and aggregate level from a Pharmacovigilance perspective with strong knowledge of Health Authority reporting requirements and guidance.
You must also have demonstrated ability to work alongside business stakeholders to understand requirements and generate Business Objects reports to satisfy those business needs.
Education, Qualifications, Skills and Experience
Essential
• Bachelor’s degree in a scientific discipline, with relevant experience in supporting safety-related activities in the context of clinical biopharmaceutical development.
• Proven competence, with minimum of 3 years Patient Safety or closely-related pharmaceutical industry experience, preferably with extensive involvement in the successful design, delivery or deployment of information/systems solutions in support of safety or PV-related work.
• Broad knowledge of the safety information and analytics tools required to support drug development and marketed brands, including a comprehensive understanding of clinical trials, regulatory safety obligations, pharmacovigilance practices, epidemiology practices, and changing safety project team activities.
• Experience in safety signal management, data visualization and reporting tools, and/or the exploitation of data used to define the safety profile.
• Knowledge of the procedures, processes and standards governing clinical trial data (documents and data) with health authorities worldwide, and experience of implementing these within the business.
• Able to identify opportunities to lead change through innovation – seeking continuous improvement based on strong awareness of external competitive practice.
Desirable
• Higher degree in a clinical or safety-related discipline.
• Significant experience (5+ years) in pharmacovigilance with proven record of supporting tools / solutions to address safety information in conjunction with IT.
• Significant experience in system validation, audit and PV inspection activities and requirements
If you are available, have the skills required and are able to take on a full time Daily rate contract - please call me or email me for more details
Glen Fairbrother 02079401212 / glenf@msipharma.com
