Pharmaceutical Safety Specialist

Company Overview

Company details are not specified.

Job Summary

The Pharmaceutical Safety Specialist will play a critical role in ensuring patient safety and regulatory compliance within the pharmaceutical industry. This position is responsible for monitoring, evaluating, and reporting safety data, contributing to a safer drug development process. The candidate will engage with cross-functional teams to achieve the organization’s goals in pharmacovigilance and safety surveillance.

Responsibilities

• Monitor and evaluate adverse event reports and safety data from various sources.
• Draft and maintain aggregate safety documents and risk management plans.
• Collaborate effectively with internal teams in a matrix environment to enhance safety data management.
• Ensure compliance with global regulatory requirements related to pharmacovigilance and safety surveillance.
• Utilize safety databases and tools to analyze and interpret safety data.
• Communicate findings and recommendations to stakeholders clearly and effectively.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field. Advanced degree (e.g., Master’s, PhD, PharmD) preferred.
• Experience:
  • Relevant experience in pharmacovigilance, safety surveillance, or drug development is essential.
  • Familiarity with drafting aggregate safety documents and risk management plans.
• Skills:
  • Strong analytical skills to assess complex data sets.
  • Excellent communication skills for effective collaboration and reporting.
  • Ability to thrive in a matrix organizational structure.

Preferred Skills

• Familiarity with safety databases and tools is advantageous.
• Comprehensive knowledge of global regulatory requirements for drug safety.

Experience

• Experience in pharmacovigilance, safety surveillance, or drug development is required.

Environment

Work environment details are not specified.