Clinical Safety Risk Management Operations
hace 1 mes
**Job Description**:
- Operational Support for Signaling which may include** support/**maintenance of:
- adverse experience review (AER) schedule for signaling, including schedules for signaling in EVDAS and Merck safety database
- new Product Family Name (PFN) notifications and product assignment changes
- removal of products from signaling activities.
- annual product tiering review process.
- Monitoring Safety Surveillance and RMST Mailbox
- Support for CSRM metrics and dashboard
- Support submission and management of IT tickets as needed
- IT requests for adverse experience review performed outside of Merck Signaling tool
- Assist in preparing and responding to requests from Regulatory Agency Inspections as well as internal and external audits.
- Support other project(s) or perform any other task related to signaling as deemed appropriate by management
**Minimum Education Requirement**:
- Bachelor's degree in a scientifically or medically-related discipline.
**Required Experience and Skills**:
- Minimum three (3) years experience in pharmaceutical industry, in health care, public health or related field.
- Advanced knowledge in Microsoft office (advanced excel)
- Knowledge in Access and Power apps
- Desirable experience in PV reports
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R220869
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