Assoc. Spclst, Drug Safety

hace 7 días

Bogota, Colombia MSD A tiempo completo

**Job Description**:
The Associate Specialist, PV is responsible for undertaking specified PV activities including projects with oversight by their manager or a designated PV colleague.

**The items listed below are activities that can be performed by the role and is applicable for all supported countries. Additional local specific tasks and responsibilities may be further described in the section below entitled “Additional Local Specific Activities”.**

Assists with execution of local PV processes and activities in collaboration with internal functional areas and external parties as assigned. Assists with day-to-day adverse events case management including case intake, tracking, translation to English (as applicable), acknowledgments, and follow-up activities in accordance with PV procedures and country regulations. Assists with Individual Case Safety Report (ICSR) Health Authority submissions in accordance with company procedures and health authority requirements, when requested. Assists with aggregate safety report submissions to Health Authorities in accordance with company procedures and health authority requirements, when requested. Responsible for filing (electronic, paper), storage and archiving safety-related and regulatory data and documentation in accordance with department and company policies and local requirements. Participates in compliance activities and assists in coordinating the preparation of necessary corrective actions locally for late reports. Supports local PV audits and inspections when requested. Supports PV self-inspections as required by PV Legislations (where applicable). Responsible for reporting adverse experiences or events (AE) or product quality complaints (PQCs) associated with the use of our company products in compliance with Corporate Policy 01: Patient Safety. Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity. May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable). May be assigned responsibility for ensuring appropriate PV language is included in country PV agreements, liaising with Alliance Managers as required, supporting local qualification/due diligence activities and compliance reviews, and assisting in maintenance of the business partner data tracking system. May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations. Support local implementation of applicable business continuity plans (as applicable). Performs other activities as requested by their Manager. May participate on special projects or rotational assignments within or outside of IPV as part of their professional development.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Project Temps (Fixed Term)

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R253257

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