Drug Safety Public Health Specialist - II
- Experience Level
- Experienced (non-manager)
A vacancy has arisen for a Drug Safety Public Health Specialist - II with an internationally renowned pharmaceutical company, based in their UK office. This organization 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 organization and support their innovative impact on the healthcare field.
- Being responsible for the generation, review, and validation of data related to a number of quality assurance activities.
- Producing a number of different compliance reports and are also responsible for Product Complaint, Medical Information, and Third Party Reconciliations, working with various functions to determine requirements for corrections, including tracking and collating responses.
- Performing analysis on trending data and escalating any continuing or significant non-compliance and performance issues.
- Gathering relevant information appropriate for a given task or activity.
- Effectively planning to receive and produce reports or data in a timely manner.
- Establishing work priorities with minimal direction from manager.
- Participating in the production of reports or data for performance metrics, quality assurance, or reconciliation activities.
- Working with internal or external third parties in the areas of performance metrics, quality assurance, and/or reconciliation activities to clarify any data inconsistencies or trends.
- Assisting in business continuity records management and PVE record retention reviews.
- Complying with new regulatory requirements in area of responsibility.
- Recognizing the need for and seeking assistance from appropriate internal and external resources in the area of responsibility.
- Highlighting areas of concern to senior staff or manager.
- Making some recommendations for improvement.
- Providing regular updates to manager, including challenges and suggested actions that could be taken.
- Maintaining confidentiality (especially on patient records) with good attention to detail and a high level of concern for accuracy and quality.
- Maintaining compliance with PVE and applicable SOPs and work instructions.
- Maintaining knowledge of company disease and therapeutic areas.
- Actively participating in S&C meetings and sharing information on projects and challenges openly.
Skills and Requirements:
- An individual with a medico-scientific university degree.
- Previous experience in drug safety or clinical research required.
- Demonstrable awareness and some understanding of applicable regulatory requirements.
- Demonstrated project management skills.
- 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 Divya Mistry at +44 2038141315 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.