We are looking for:
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.
Currently in PPD Serbia, we are looking for Safety Reporting Specialist.
He/She will be 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
- Prepares and submits expedited safety reports to applicable parties which may include regulatory agencies, ethics committees, investigators and third parties
- Ensures reports are submitted within the regulatory timelines to ensure compliance
- Tracks all expedited safety report submissions and review compliance/produce metrics on a regular basis
- Assists in any specific tasks, safety issues or concerns and liaise closely with Clinical, PVG, and Regulatory Affairs teams
- Assists in the testing of any study tracking databases and provide input into database design as required
- Assists in archiving study files as required
- Completes all tasks in accordance with relevant SOPs/WPDs and departmental guidelines
- Ensures regulatory submission files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
- Facilitates and responds to company, client and regulatory audits where required
- Bachelor’s degree in the life-science field or previous CRO experience is required
Knowledge and skills required
- Strong attention to detail
- Excellent written and verbal communication skills
- Good Microsoft Word and Excel skills; basic understanding of database functionality
- Ability to identify and set priorities and effectively perform a variety of tasks simultaneously, including those with set deadlines
- Knowledge of medical terminology
- Ability to maintain a positive attitude
- Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff members
- Ability to work effectively within a team to attain a shared goal
- Demonstrates initiative and completes assigned tasks with limited supervision
- Ability to maintain focus while working within strict timelines
- Strong critical thinking and problem solving skills
How to apply? Please submit your CV in English.
Deadline for applications: 20.10.2019.