Pharmacovigilance Scientist

Manage activities relating to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed and investigational human and veterinary products in accordance with the applicable regulatory requirements. Aggregate report preparation [e.g. Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)] from aggregate data for products, in accordance with client conventions and requirements; Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses.

Minimum qualification (s):
Master s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology or Biophysics) or a degree in Dentistry or Bachelor degree in Veterinary Sciences (B.V.Sc.) or Post-Graduation in Veterinary Sciences (M.V.Sc.); experience in the Pharmacovigilance industry would be an advantage. Good knowledge of medical terminology, fluency in written and spoken English, computer proficiency, an ability to work with web-based applications, and familiarity with the Windows 10/ Window 7 professional operating system and the MS Office suite (Word/Excel/Power Point), capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text, ability to evaluate data and draw conclusions independently, strong written and oral communications skills are required.