Senior Safety Data Specialist

hace 1 día

San José, Costa Rica Msd A tiempo completo

**Job Description**:
**Responsibilities and Primary Activities (may include but are not limited to)**:

- ** Performs all core responsibilities of the Senior Safety Data Specialist (SSDS) in addition to processing of the most complex AE reports.
**:

- ** Independently and consistently meets Key Performance Indicators (KPIs) for quality and compliance.
**:

- ** Assists GPVCM Management to identify opportunities for business and/or operational process improvement to ensure/improve Quality and Compliance as well as increase efficiency and effectiveness.
**:

- ** Assists GPVCM Management to prepare and respond to Regulatory Agency inspections as well as internal and external audits.
**:

- ** Monitors and analyzes key performance indicators to ensure adherence at process level and overall GPVCM team level.
Assists with root cause analysis and oversees implementation of action plans when appropriate.
**:

- ** Serves as a GPVCM expert to effectively interact and communicate with internal and external stakeholders for the resolution of complex issues.
Organizes and/or actively participates in the global network within GPVCM or with stakeholders to discuss process issues or inconsistencies, to create solutions, and works with Global Pharmacovigilance as appropriate to improve, standardize and optimize processes.
**:

- ** Provides process expertise and conducts periodic assessments (if needed) to ensure established processes are being followed consistently and appropriately.
**:

- ** Coordinates and performs quality and compliance assurance/control related processes and tasks.
**:

- ** Initiates and coordinates updates of guidance documents to guarantee global deliverables and alignment.
Assists managers with the development and implementation of departmental procedures and educational programs.
**:
**Education and other Qualifications**:

- ** Bachelor's Degree in Health Care or role related discipline**:

- ** Master's degree desired**:

- ** Advanced writing/reading and advanced speaking/listening English language skills**:

- ** Minimum 2 years' experience in in Pharmacovigilance or role related field**:
**Levels required for Core Competences (Classifications of the levels from the lowest to the highest: Learning, Applying, Advanced and Expert)**:

- ** Professional Competencies**:

- ** Working Across Boundaries (Applying).
**:

- ** Strategic Thinking (Learning)**:

- ** Project Management (Applying).
**:

- ** Productive Communication (Applying).
**:

- ** Problem Solving (Applying).
**:

- ** Core Functional Competencies**:

- ** Data Analysis, Interpretation & Communication (Applying).
**:

- ** Competitive Decision Making & Execution (Learning).
**:

- ** Collaboration & Partnering (Applying).
**:

- ** Business & Operations Management (Applying).
**:

- ** Regulatory & Compliance Management (Applying).
**:

- ** Disease Area Knowledge**:
**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Temporary (Fixed Term)

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R225035

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