Medical Safety Specialist
2 semanas atrás
Job Overview
We are seeking a highly skilled Medical Safety Specialist to join our team at PrimeVigilance. As a Medical Safety Specialist, you will play a crucial role in reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment.
Key Responsibilities
- Review and approve post-marketing ICSRs and SAE reports
- Act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance
- Review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy
- Review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety-related findings
- Cooperate in the preparation of and provide input in Risk Management Plans
Qualifications
- Medically qualified as a physician
- Previous experience in pharmacovigilance
- Ability to review different aggregate report types including PBRERs and DSURs
- Expertise in signal detection activities is essential
About PrimeVigilance
At 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. We offer training and career development opportunities internally, a strong emphasis on personal and professional growth, a friendly and supportive working environment, and the opportunity to work with colleagues based all over the world, with English as the company language.
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