Patient Safety Systems Aggregate Reporting Consultant

Job title : Patient Safety Systems Aggregate Reporting Consultant
Location : Cambridge
Job type : Contract/Freelance
Salary : Negotiable
Contact name : Pauline Markina
Contact email :
Employment type: Contract
Duration: 6 months
Location: Cambridge

Candidate outline:
* Highly proficient in Health Authority / country-specific requirements for Patient Safety reporting at an individual case and aggregate level from a Pharmacovigilance perspective.
* Strong knowledge of Health Authority reporting requirements and guidance
* Demonstrated ability to work alongside business stakeholders to understand requirements and generate Business Objects reports to satisfy those business needs

Job description:
The role holder focuses on delivering solutions and systems to address Business as Usual (BaU) in order to meet regulatory compliance. Develops standardised operating procedures and best practice in order to ensure effective and efficient delivery of safety information across the organisation. Demonstrates knowledge of safety / pharmacovigilance system requirements in order to meet business needs against the prioritised product portfolio. Provides comprehensive technology evaluation and and ongoing stakeholder and vendor relationship management.

Typical accountabilities:
* Provides global knowledge for product, process, and database knowledge to ensure safety information is effectively evaluated in the most efficient manner while remaining aligned with strategic direction across the business.
* Manages applicable tools and methodologies to ensure existing processes and systems fully address the needs of the stakeholders.
* Identifies opportunities where innovative solutions and continuous improvement plans should be better aligned with best practice across the industry.
* Provides input on the development of strategic and tactical plans for technical regulatory and safety knowledge to stakeholders and project teams across the enterprise

* 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.