Pharmacovigilance Physician
PSI CROAbout the role
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
- Medical review of incoming serious adverse event (SAE) and
other reportable adverse events - Produces medical queries for incoming safety information
- Preparing case narratives for SAE and other RAE reports
- Writing periodic safety reports to regulatory agencies
- Monitoring, evaluation, and interpretation of safety data
- Communication with clients, investigative sites, internal team regarding safety matters
- Prepare and deliver presentations on safety matters
Qualifications
- Medical Doctor degree
- At least 2 years of clinical experience or experience in Clinical Research
- Knowledge of safety review process, medical terminology and coding dictionaries
- Knowledge of regulatory requirements governing safety reporting
- Full working proficiency in English and Spanish
- PC skills to be able to work with MS Word, Excel and PowerPoint
- Ability to plan, multitask and work in a dynamic team environment
Only CVs in English will be considered.
Additional Information
In this role, you will provide medical input to the safety matters within global clinical studies. You will join a team of solution-oriented medical experts who have in-depth understanding of study requirements, ensure patient safety, review clinical trial documentation and assess medical issues.
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