Senior Manager, Risk Management
A vacancy has arisen for a Senior Manager, Risk Management with an internationally renowned pharmaceutical company, based in their UK office. This organisation is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organisation and support their innovative impact on the healthcare field.
- Authoring and coordinating cross functional contributions to Clinical Trial Safety Reporting Procedures (CTSRPs).
- Working with internal and external parties to clarify any inconsistencies or issues with responsibilities and terms and conditions described in the CTSRP.
- Planning effectively to create, update, and maintain CTSRPs in a timely manner.
- Highlighting areas of concern to manager; making recommendations and implementing processes for improvement.
- Establishing work priorities with minimal direction from manager.
- Providing regular updates to manager, including challenges and suggested actions that could be taken.
- Participating in S&C meetings and sharing information on projects and challenges openly.
- Recognising potential or impending problems; implementing and delivering solutions.
- Maintaining compliance with PVE and applicable SOPs and work instructions.
- Maintaining knowledge of company disease and therapeutic areas.
- Developing solutions to complex problems which require the regular use of ingenuity and innovation, ensuring solutions are consistent with organisation objectives; contributing to the development of new concepts, techniques, and standards.
- Serving as consultant to PVE management in area of expertise and acting as a spokesperson for the PVE organisation in matters pertaining to its policies, plans, and objectives in their area of expertise.
- Making and affecting decisions that are long-lasting and influence the future course of the PVE organisation.
Skills and Requirements:
- Scientific background with a medico-scientific university degree.
- Previous experience in multiple aspects of pharmacovigilance activities.
- Project management experience preferred or experience in managing complex projects.
- Working knowledge of global safety regulatory requirements.
- Proven good communication skills and evidence of ability to work in cross functional teams.
- Demonstrates excellent scientific/clinical or analytical knowledge base, with ability to assess data and understand the safety/medical or process implications.
- Competent in abilities in area of expertise and the wider areas of PVE
- A good knowledge and understanding of applicable regulatory requirements.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Ronni Hartgen at +44 2038000814 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.