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drug safety associate

  • Handling of non-serious and serious adverse events. ·        
  •  Perform initial evaluation of reported adverse events (serious and non-serious) from all sources.
  •  Perform case entry and verification of reported non-serious and serious adverse events; enter the reported information in the Novo Nordisk safety database – Argus, on the basis of individual case histories, correspondence with affiliates/sites and other departments in headquarters (HQ) and various administrative assignments.
  •  Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).
  •  Evaluate causality, seriousness and listedness for all cases.
  •  Ensure that case narrative comprises correct and appropriate safety information.
  • Assess the need for follow up information and issue follow up requests for all cases and post queries in EDC and/or to affiliate.

drug safety associate

  • Experienced in Clinical Trial and Post Marketing
  • Scheduling regulatory reports with the regulatory timelines
  • Importing the cases from the EudraVigilance site
  • Quality checking the reports.
  • Training the team on basics of PV

senior drug safety associate

  • Drug safety and regulatory submission services for a globally elite pharmaceutical and therapeutic client as vendors. Services include but are not limited to:
  • Plan, organize, and manage daily work to meet service level timelines and deliverables with responsible for alerting the fellow team members (via e-mail) of errors found in pertinent fields within 24 hours from detection.
  • Review cases for errors, missing information, and legibility. Ensures cases are processed per conventions, and regulations.
  • Conduct Quality Huddle for team discussing the ongoing trends in error and cascading the latest process updates to team.
  • Evaluates adverse event reports, assesses regulatory status which is seriousness and expectedness/relatedness in order to prioritize workload and ensure timely submission.
  • May perform risk and quality function on adverse event reports including manual coding as needed.
  • May determine need for and request follow-up using appropriate communication methods (ex: fax, email, telephone or site visit).

drug safety associate

  • Review and process SAEs, spontaneously reported ADRs, Literature reports, Intake of ICSRs and other medically related information in ARGUS safety database.
  • Performs or approves triage of SAEs with regard to seriousness and reporting.
  • End to end Data entry including Medical coding and Safety Narrative.
  • Responsible for CAPA writing & late case analysis.
  • Monitoring the Service Level Agreements.
  • Follow up on reconciliation discrepancies. 

drug safety associate

  • Initial receipt, Database searches as necessary. Registry and triage of incoming cases to determine seriousness for prioritizing of daily workflow
  • Completion of case processing (case data entry, labeling, approval numbers, manual coding, narrative writing) and quality review
  • Clarification of unclear or illegible information from the Local Safety Officer or Call Center and customer communications as per project requirement
  • Discuss source documents, coding conventions and queries with Pharmacovigilance Physician
  • Completion of Protocol request forms
  • Preparation of deviation memo
  • Request deletions/Admin edit requests