Safety Data Specialist
A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Safety Data Specialist. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.
Information Strategy, Systems and Analytics (ISSA), as a part of Global Regulatory Affairs, Patient Safety and Quality Assurance (GRAPSQA), has a special role in the development of medicines and in ensuring 's license to operate by developing, maintaining, implementing, and continuously improving processes and standards related to the handling, exploitation and timely reporting of safety information, as required by regulatory authorities worldwide.
The strategic goals of ISSA require a portfolio of information assets, systems and related expertise to be managed in line with an overall safety information strategy, and to address the business needs of the ISSA organization, its partners and customers.
We are looking for an enthusiastic Scientist to join our department to work with the Senior Scientists and the Experts for Pharmacovigilance Systems in the evaluation of technology, as well as, in the management of stakeholders and vendor relationships. You will also evaluate User Requirement Specifications (URS) and Benefit Realization Plans (BRPs) aligned with the safety database and will also participate in the evaluation of new safety tools and applications. The latter includes innovative solutions which have the potential to enhance current and future Patient Safety capabilities, improve delivery or integration of scientific information, and/or enable compliance requirements to be met in a more effective or cost-efficient manner.
- Evaluate products, processes, and databases to ensure safety information is effectively reported in the most efficient manner while remaining aligned with strategic direction across the business.
- Manage the Pharmacovigilance toolset and corresponding methodologies, ie, the global safety database and specific Marketing Company systems, to ensure existing processes and systems fully address the needs of the stakeholders.
- Identify and employ innovative solutions and continuous improvement plans to ensure alignment with best practice across the industry.
- Provide input on the development of strategic and tactical plans for technical regulatory and safety knowledge to stakeholders and project teams across the enterprise.
- Be accountable for understanding pharmacovigilance reporting needs of the customers and translating these needs into business requirements to address future information and systems solutions in support of necessary / critical business capabilities.
- Evaluate new modules and software upgrades and assesses the impact on system validation, the user community and standardized processes related to the pharmacovigilance area of ISSA. Retains a global perspective of the business need for accurate, high-quality, effective and efficient information and systems resources, while maintaining a focus on regulatory and corporate compliance needs.
- Be responsible for serving as conduit between business, technical team, and vendors, working to ensure business needs are appropriately addressed via technical solutions, and, that vendor delivery is within required performance metrics.
- Collaborate closely across the global GRAPSQ organization, with stakeholders, IS vendors, and other experts involved in the design, development and delivery of information and analytics solutions, or related business deliverables such as policies, procedures, processes and guidance.
- Work globally, interacting across all levels of staff and locations
Skills and Requirements:
- Bachelor's degree in a scientific discipline, with relevant experience in the technical support of safety-related activities in the context of clinical biopharmaceutical development.
- Proven competence, within Patient Safety or closely-related pharmaceutical industry experience, preferably with involvement in the successful design, delivery or deployment of information/systems solutions in support of safety or PV-related work.
- Proven competence with global safety databases and reporting tools.
- Previous experience in the role of Business Tool manager within a safety database, working with business requirements and vendors, to deliver optimal solutions.
- Broad knowledge of the end-user needs from a safety reporting tool in order to support drug development and marketed brands, including an understanding of clinical trials, regulatory safety obligations, pharmacovigilance practices, and changing safety project team activities.
- Knowledge of the procedures, processes and standards governing clinical trials (data and documents) with health authorities worldwide, and experience of following these within the defined business area.
- Demonstrated ability to work through tasks associated with continuous improvement processes
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 Jon Stewart on +44 203 7520 318 or upload your CV 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.