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Drug Safety Associate
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#769909
Remote / WFH
Scoutit
Job Description
We're looking for Drug Safety Associates!
Responsibilities
• Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines
• Monitor and download ICSRs from Eudravigilance (EV) for valid ICSRs
• Processing literature, spontaneous as well as clinical trial and solicited cases
• Schedule and perform search of literature reports for valid ICSR in PubMed and MLM
• Responsible for generation of reports and submission to health authority and business partners
• Ensure data entry of serious and non-serious ICSRs (Spontaneous, Solicited and literature) in ARGUS as per client SOP and WI with high level of data accuracy
• Responsible for coding events, indications and patient history based on MEDDRA
• Coding of suspect products as well as concomitant., Amending the narrative when required, Performing Labeling of events
• Responsible to obtain follow-up information for all serious and non-serious cases as per the guideline on Good Pharmacovigilance Practices (EU-GVP).
• Perform the submission of the processed cases to regulatory authority and report distribution to Partner.
• Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate
• Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines
• Track and perform daily and monthly reconciliation of ICSRs as per client requirements
(*Note: Scoutit is an independent candidate sourcing partner for this hiring. All applications, candidate screening, and hiring-related actions are conducted directly by the respective employer’s authorized recruitment team. Relevant candidates will be contacted via email and asked to fill in additional details as part of the next stage of the application process.)
Skills: health,databases,gvp
Responsibilities
• Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines
• Monitor and download ICSRs from Eudravigilance (EV) for valid ICSRs
• Processing literature, spontaneous as well as clinical trial and solicited cases
• Schedule and perform search of literature reports for valid ICSR in PubMed and MLM
• Responsible for generation of reports and submission to health authority and business partners
• Ensure data entry of serious and non-serious ICSRs (Spontaneous, Solicited and literature) in ARGUS as per client SOP and WI with high level of data accuracy
• Responsible for coding events, indications and patient history based on MEDDRA
• Coding of suspect products as well as concomitant., Amending the narrative when required, Performing Labeling of events
• Responsible to obtain follow-up information for all serious and non-serious cases as per the guideline on Good Pharmacovigilance Practices (EU-GVP).
• Perform the submission of the processed cases to regulatory authority and report distribution to Partner.
• Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate
• Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines
• Track and perform daily and monthly reconciliation of ICSRs as per client requirements
(*Note: Scoutit is an independent candidate sourcing partner for this hiring. All applications, candidate screening, and hiring-related actions are conducted directly by the respective employer’s authorized recruitment team. Relevant candidates will be contacted via email and asked to fill in additional details as part of the next stage of the application process.)
Skills: health,databases,gvp
