Merck Group hiring Expert – Clinical Safety Operations

Merck Group hiring Expert – Clinical Safety Operations

15 June, 2022

Merck Group hiring Expert – Clinical Safety Operations (Project & Program Management., Global customers/ stakeholders, Vendor Management.)

The Expert – Clinical Safety Operations is responsible and accountable for:

  • Contribute to and oversee safety aspects on EAC, CU programs.
  • Standard operating procedure (SOPs), Working Instructions (WI) reviews, inputs, knowledge, and understanding.
  • Review Informed Consent Form (ICF) and input for safety related sections.
  • Review Protocol for safety related sections.
  • Review Investigator sponsored studies (ISS) agreement.
  • Setup and manage Early Access Program (EAP) and Compassionate Use (CU).
  • Contribute to Request for proposal reviews and Vendor Selection.
  • Contribute to defining and implementing clinical trial safety related activities in the Alliance with relevant partners/service providers of org. and alignment of guidelines and processes related to clinical trial safety management with existing GDS processes.
  • Responsible for Safety Management Plan SMP), including review and oversight.
  • Maintenance of Reference Safety Information (RSI).
  • Oversight on Safety Monitoring Committee (SMC)/ Data Monitoring Committee (DMC) Coordination of activities.
  • Review of Electronic Case Report Form (eCRF) for safety related sections.
  • Oversight on Serious Adverse Event (SAE) and ISS reconciliation.
  • Oversight on Query management within Common Communication Module (CCM tool).
  • Act as a subject matter expert (SME) for COMPASS database.
  • Review Electronic Trial Master File (eTMF) for safety relevant core documents.
  • Contribute to Trial Oversight Plan (TOP) for safety relevant sections.
  • Contribute to the improvement of routine pharmacovigilance activities throughout the process lifecycle.
  • Liaise between internal/ external stakeholders as needed.
  • Contribute during audits and inspections as assigned. Liaise with Quality Assurance for completion of CAPA plans.
  • Work closely with internal and/ or external partners to manage development, testing, and use of electronic systems necessary for CSO processes.
  • Apply expertise in aligned areas and mentor developing specialists, less experienced, or newer staff members.
  • May provide oversight role on operational and collaborative tasks as directed by manager or Head of Clinical Safety Operations.
  • Participate in team meetings and provide regular feedback on operations, issues, and successes.
  • Contribute to the achievement of departmental goals.
  • Ensure all required training is executed within the stipulated period.

Apply HERE

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