Safety Officer

Company Description

PSI is a leading Contract Research Organization with more than 28 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

Safety reporting is incredibly important in the development of new medications. Join our global Pharmacovigilance team and address safety matters in an accurate and timely manner. You will build a career on the frontline of clinical research, while identifying risks associated with investigational products and ensuring better patient protection.

You will:

• Develop study-specific safety management plans
• Set-up and maintain project and product-specific safety databases
• Participate in the review and triage of incoming SAE reports
• Prepare narratives for reportable adverse events
• Be a point of contact for investigative sites, clients, in-house project teams regarding safety information
• Support periodic safety reporting to regulatory agencies and address their questions
• Develop and implement training in safety aspects of clinical research
• Assist in preparation for the audits and inspections in the matters of safety reporting

Qualifications

• University degree in Life Sciences or PharmD or an equivalent combination of education, training & experience
• PhD is a plus
• Minimum 2 years of experience in clinical or academic research
• Minimum 1 year of relevant experience in safety reporting
• Knowledge of safety review process, regulatory requirements (ICH, FDA, EMA, local), governing safety reporting, databases used for safety information warehousing and reporting, and medical terminology and coding dictionaries
• Full working proficiency in English
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Analytical skills and ability to work with large amounts of information
• Communication and organizational skills

Additional Information

Make the right call and take your career to a whole new level.  Join the company that focuses on its people and invests in their professional development and success.