Pharmacovigilance Specialist

Company Overview

Not specified.

Job Summary

The Pharmacovigilance Specialist plays a vital role in ensuring the safety and efficacy of pharmaceutical products by monitoring, assessing, and reporting adverse drug reactions. This position contributes to the organization’s commitment to patient safety through the management and evaluation of safety data in compliance with regulatory standards.

Responsibilities

• Monitor and assess safety information related to pharmaceutical products.
• Draft and prepare aggregate safety documents and risk management plans.
• Manage and maintain safety databases and tools to ensure accurate data reporting.
• Collaborate with cross-functional teams to ensure effective communication regarding safety issues.
• Conduct safety surveillance activities in accordance with global regulatory requirements.
• Analyze safety data and provide insights for risk-benefit assessments.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (e.g., Master’s, PhD, PharmD) in Life Sciences or a medical field preferred.
• Experience: Proven experience in pharmacovigilance, safety surveillance, or drug development.
• Knowledge: In-depth understanding of global regulatory requirements related to drug safety and management of safety data.
• Skills:
  • Strong analytical skills for evaluating complex data.
  • Excellent communication abilities to effectively convey safety information.
  • Capability to work effectively within a matrix environment.

Preferred Skills

• Familiarity with safety databases and pharmacovigilance tools.
• Experience in drafting risk management plans and collaborating with regulatory agencies.

Experience

Details on minimum or specific years of experience are not specified, but prior experience in the relevant areas is expected.

Environment

The typical work setting, location (remote, in-office, hybrid), and any physical or environmental conditions relevant to the job are not specified.

Salary

Salary details are not specified.

Growth Opportunities

Information regarding potential career advancement opportunities within the company is not specified.

Benefits

Details on offered benefits such as insurance, paid leave, or work policies are not specified.