Safety Specialist

Job Description

Job Summary:

• Under supervision of the Deputy LSO US – Operations Lead, the individual is responsible for contributing to daily activities to ensure a compliant Pharmacovigilance (PV) system in order to protect public health and maintain compliance with applicable regulatory requirements.

Duties and Responsibilities:

• Manage US postal follow-up activities.
• Independently address queries raised by affiliate/global follow-up team in accordance with internal procedures.
• Provide administrative support to Product Management team by liaising with marketing team project/program owners to ensure proper documentation is in place, in accordance with SOPs, for programs with Pharmacovigilance impact.
• Ensure timely updates to various tracking tools.
• Provide back-up and administrative support as required during US affiliate transition to the new safety database.
• Support US team in providing Pharmacovigilance Training to vendors/in-house personnel as required.
• Support proper archival of US Safety documentation/forms.
• Maintain current knowledge of drug safety regulations and procedures.
• Perform other responsibilities and projects as assigned by manager/company.

Qualifications and Skills:

• Bachelor’s Degree.
• Education in a health-related area highly preferred with basic knowledge of medical terminology.
• Minimum 1-2 years of Pharmacovigilance experience preferred or advanced clinical degree (i.e., RN, PharmD) in lieu of direct PV experience.
• Some understanding of Pharmacovigilance and related obligations.
• Creative and persistent problem solver.
• Recognize areas of process improvements related to the function and provide feedback to management.
• Takes ownership of meeting high standards.
• Ability to prioritize, organize, and plan.
• Proficiency with safety databases and MS Office applications.
• Ability to network and effectively communicate with international teams.

Problem Solving:

• Proactive and independent problem solver.
• Quality oriented.
• High level of creative and innovative thinking.

Work Arrangement:

• Required to use personal laptop for work, as the client will not be supplying any equipment.