Senior Safety Data Specialist

hace 7 días

San Vicente Ferrer, Colombia MSD A tiempo completo

The **Senior Safety Data Specialist (SSDS)** is responsible for processing adverse events (AE) reports of higher complexity with high quality and compliance in the global safety system for investigational and/or marketed products, under the direction and supervision of a GPVCM Manager. The SSDS performs triage, analysis and interpretation of AE data following our Company Standard Operating Procedures (SOPs) and guidelines. The SSDS supports business processes which are important to GPVCM operations and works closely with other staff within the organization as well as cross-functionally.

**Secondary** Language(s) Job Description**:

- Through daily case prioritization activities, ensures completion of reports within the established internal, business partner and regulatory agency timelines.
- Ensures quality and consistency with guidelines.
- Performs case translation and/or submission in compliance with requirements of worldwide regulatory agencies.
- Indexes AE documents pushed from Central Receiving Mailboxes to the Imaging system with required attributes.
- Clarifies discrepancies in the incoming information to achieve unequivocal text in a standardized form.
- Effectively communicates with internal and external stakeholders on any inquiry or request.
- Exchanges communication with Business Partners (BPs) following agreements, to ensure compliance with internal, BP and worldwide regulatory agency reporting requirements.
- Successfully completes training and independence assessment activities for GPVCM specialists.
- Performs all core responsibilities of the Safety Data Specialist in addition to cross-training and processing of higher complexity AE reports.
- Independently and consistently meets Key Performance Indicators (KPIs) for quality and compliance.
- Serves as a Point of Contact, providing feedback and support to ensure resources (SOPs, guidelines)

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)**Relocation**:
No relocation**VISA Sponsorship**:
No**Travel Requirements**:
No Travel Required**Flexible Work Arrangements**:
Flex Time**Shift**:
**Valid Driving License**:
No**Hazardous Material(s)**:
**Requisition ID**:R169260

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