We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
The Medical Reviewer II is responsible for medical review of lCSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS/PBRERs/PADERS) as required by the Company or Client.
For the Client:
For the Company
Why PrimeVigilance
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.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
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Join PrimeVigilance as a Medical Reviewer II in Bucharest, Romania, where you'll play a vital role in ensuring the safety and efficacy of medical therapies. In this dynamic position, you will be responsible for reviewing Individual Case Safety Reports (ICSRs), assessing Serious Adverse Events (SAEs), and writing comprehensive signal detection reports. Working closely with our dedicated teams, you'll help write and review aggregate reports like Development Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs). At PrimeVigilance, we pride ourselves on fostering a collaborative and supportive atmosphere, emphasizing continuous training and development for our team members. Your expertise in pharmacovigilance will be paramount as you collaborate with cross-functional teams to prepare responses to regulatory inquiries and craft Risk Management Plans. With a focus on work-life balance, we have cultivated an environment where our employees can thrive and contribute to transforming lives positively. If you're a medically qualified physician with a passion for patient safety and a knack for signal detection activities, PrimeVigilance is the perfect place for you to advance your career and make a real difference in the pharmaceutical landscape.
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