Company Description
PSI is a leading Contract Research Organization with more than 27 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
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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
Additional Information
- University degree in Life Sciences or PharmD or an equivalent combination of education, training & experience
- PhD is a plus
- Experience in clinical or academic research
- Relevant experience in safety reporting
- 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.
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