Medical Reviewer Ii Specialist
3 semanas atrás
We are PrimeVigilance, a leading mid-size pharmacovigilance service provider. Our team is dedicated to delivering first-class support to pharmaceutical and biotechnology partners worldwide.
As a Medical Reviewer II Specialist, you will play a crucial role in maintaining long-lasting relationships with our clients by reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment.
The review includes coding, seriousness assessment, company causality and comment, listedness/expectedness and follow-up questions. You will also act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance in the medical understanding and evaluation of any safety issues.
You will be responsible for reviewing and providing input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy, and cooperating in the preparation of Risk Management Plans.
In addition, you will review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings.
A strong background in pharmacovigilance and expertise in signal detection activities is essential. You will work closely with our cross-functional teams to identify potential signals and propose a course of action.
We offer a competitive salary range of $80,000 - $110,000 per annum, depending on your experience and qualifications. Our benefits package includes training and career development opportunities, a friendly and supportive working environment, and the opportunity to work with colleagues based all over the world.
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow.
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