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.