Safety Officer

Company Description

PSI is a leading Contract Research Organization with more than 27 years 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.

Office-Based in Belgrade

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 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 and Serbian

▪         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

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.