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Pharmacovigilance organisations regularly need Drug safety physicians for management of benefit-risk profile, Identification and investigation of safety signals for the assigned post marketing products. The benefit risk profile also includes Review and analysis of safety data from post marketing sources and from clinical trials. A Drug Safety Physician is expected to demonstrate strong medical knowledge and analysis for ICSR reports, safety documents (e.g. PSURs/PBRERs, signal analysis, RSI, regulatory enquiries, risk management plans). Additionally they need strong knowledge regarding international regulatory requirements like ICH, European Pharmacovigilance legislation, FDA and CIOMS etc.
• Fresher Level job in Pharmacovigilance is DSA (Drug Safety Associate). A Drug safety Associate is mainly involved in case creation, checking for MSI (Minimum safety information - a patient, a reporter, a suspect drug and a adverse event), reconciliation and follow up process, data entry of all information available in the document and medical coding
• 3 Years of experience builds more skill sets as (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance etc) which can bag him a position as DSS (Drug Safety Scientist).
• With a Certification in Pharmacovigilance and an overall of 5+ Years experience, candidates can become a Team lead or Team manager based on the company.
Students can download the admission form by clicking here, in PDF format print and fill the same, clearly mentioning Mobile No & Course Interested.