PRA Health Sciences is one of the world’s foremost global clinical research organizations (CROs). Leading with science and innovation, the company provides global clinical drug development. At our office in Swansea we currently have an outstanding opportunity for a Senior Manager of Drug Safety Center.
Lead your team to be the best! You will manage the group Drug Safety Associates and other personnel within the Drug Safety Centre to provide services for SAE/ADR management, periodic safety reports, SOPs, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance.
You will provide leadership in the implementation of PRA’s quality initiatives and business processes and possess the following skills:
- Developing, implementing, and monitoring team profitability, objectives, and metrics
- Managing operational functions of a Drug Safety Associate group within the Drug Safety Centre to meet project objectives with SAE/ADR management, periodic safety reports, safety consulting on processes, tools, regulatory requirements related managing the safety of drugs, vaccines and devices
- Building and aligning a technical team to perform critical operating tasks to achieve results
- Identifying and implementing process improvements and other ways to improve efficiencies
- Technical oversight of the generation of project plans such as Safety and Medical Management plans (SMMP) in close cooperation with project team during set-up phase
- Maintaining familiarity with current industry practices and regulatory requirements that affect analysis and reporting, submissions of NDAs and PLAs
- Interacting with clients and participating in client meetings as necessary to support and maintain new business; Reviewing group-related project tasks; providing leadership in the delivery of related services to clients;
- Ensuring that staff fulfil their responsibilities in accordance with policies, procedures, and SOPs
Location: Swansea, UK
In addition to this experience, we are looking for candidates who are excited by new and evolving technology and who want to work in a dynamic team where timely and proactive communication is critical to success.
We require substantial pharmaceutical or contract research organization experience including project leadership and management of technical staff required as well as knowledge relevant to ICH statistical analysis guidelines, report writing guidelines and regulatory submission requirements for human drugs in NA and Europe. Fluency in English is required.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.