We are looking for:
Sr Safety Reporting Specialist
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 21,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.
Responsible for all submissions within regulatory timelines, to appropriate quality standards and following PPD procedures. Assists management in producing study metrics (e.g. letters submitted for each study per month) as required.
Overview of the role:
- Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis
- Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory timelines
- Provides input and feedback to aid the development of program and departmental procedural documents
- Shares ideas and suggestions with team members. Takes an active role in the development and implementation of ideas and suggestions
- Liaises with relevant departments around safety reporting tasks and attends various meetings as required
- Provides input, feedback and guidance to other team members and mentors new starters
- Produces metrics and has some involvement in financial project
- Bachelor’s degree in the life-science field or previous CRO experience is required
- Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 5+ years)
Knowledge and skills required:
- Excellent knowledge of medical terminology
- Excellent Microsoft Office skills and good understanding of database functionality
- Excellent knowledge of procedural documents and thorough understanding of global safety reporting requirements
- Good time management and multi-tasking skills
- Strong attention to detail
- Ability to influence at all levels of the organization
- Ability to work well in a collaborative team environment
- Demonstrated initiative and utilizes persuasion and negotiation skills
- Excellent critical thinking and problem-solving abilities
- Ability to apply knowledge, skills, and expertise to assist lower-level colleagues in safety reporting activities
How to apply? Please submit your CV in English.
Deadline for applications: 20.10.2019.