Senior Pharmacovigilance Scientist
*Senior Pharmacovigilance Scientist, Data Transformation -Pharma - 12-month contract*
My client is a Global Pharmaceutical company and they have a position available for a Senior Pharmacovigilance Scientist for an initial 12- month contract.
Within this role the Senior Pharmacovigilance Scientist will be responsible for developing and driving, operational strategy for the transformation and delivery of data in order to meet both current and future requirements for a variety of safety related data outputs. They will have full ownership and oversight of the case processing process performed by the team and the vendor via the utilisation of current/future safety systems, and partners to ensure that the quality/usability of ICSR outputs conforms with agreed customer requirements. You will build strong global networks across the company and maintain an external network and an appreciation of methodological and technological advances in the management of safety-related data is critical, as efficient management of ICSR data will increasingly rely on an evolving approach.
? Responsible for the end to end case processing business process and must have applicable oversight, including monitoring compliance of the case processing process via appropriate metrics/KPIs. This includes supporting the development and implementation of processes and relevant human interventions (eg human in the loop) activities for AI augmented activities that permit oversight of operational ICSR delivery and quality.
? Ensuring inspection readiness, and is the primary point of contact (POC) for audits and inspections
? Leading change initiatives and improvements to the case processing process (e.g. impact assessment of revised legislation in reference to process changes and training), collaborating and obtaining endorsement from the ICSR Global Process Owner (GPO) for major changes in the business process affecting the global process. Responsible for synchronising process improvement plans with other process owners within the value chain and other interfacing processes
? Provide subject matter expertise into the design and improvement of processes, and appropriate documentation, including development of metrics, KPIs and business information to support decision making. Extend this to the management of non-ICSR data types.
? Governance of the case processing process in collaboration with case processing process experts
? Partner and influence globally, both across and outside the company in the use of relevant new methods and technologies (eg artificial intelligence) for safety data processing.
In order to apply for the Senior Pharmacovigilance Scientist contract, you should possess:
? Significant Pharmaceutical industry experience, in pharmacovigilance. Prior experience in business process management would be an advantage.
? Excellent knowledge of global Pharmacovigilance regulatory obligations.
? Proven abilities in managing objectives and priorities efficiently and to effective conclusions.
? Excellent team player, with a proven ability to effectively lead projects and teams.
? Well-developed influencing and negotiating skills, with the ability to influence at all levels of an organisation, without direct authority.
? Good conflict management and resolution skills.
? Creative problem solving in a complex, process-focused environment.
? Excellent interpersonal skills, builds strong sustainable relationships with internal and external stakeholders
? Proven track record of effective decision-making; makes good business decisions and exercises sound judgment
? Ability to connect people, ideas and initiatives, facilitating relationship management across the organisation
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on .