Safety Writer - Aggregate Reporting (AR)
Company Name: Clini Vigil Pharma
PBRER / PSUR (Periodic Benefit-Risk Evaluation Report / Periodic Safety Update Report), PADER (Periodic Adverse [Drug] Experience Report), RMP (Risk Management Plan), and Signal detection activities.
Good understanding and knowledge of aggregate safety report writing guidelines, and clinical trial and post-marketing pharmacovigilance legislation in relation to medicinal products.
Experience in authoring aggregate safety reports
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Education and Experience:
B. Pharma/M. Pharma/BDS 1 year of pharmacovigilance experience in Aggregate reporting