Pharmacovigilance Specialist

Placements24; Queenstown; Hybrid; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Performance incentives

Home office setup

Flexible working hours

PV training

Job summary

Placements24 is seeking a Pharmacovigilance Specialist for a fully remote role serving global safety operations. You will collect, evaluate, and report adverse events, ensuring timely compliance with regulatory requirements and data integrity while collaborating with clinical, medical affairs, and QA teams.

The ideal candidate has a degree in Pharmacy or life sciences, at least 3 years in pharmacovigilance, strong medical terminology, and proficiency with PV databases and MS Office.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field.
• Minimum of 3 years experience in pharmacovigilance or drug safety.
• Thorough understanding of global pharmacovigilance regulations (ICH, GVP).
• Experience with adverse event reporting systems and PV databases.
• Strong medical terminology and analytical skills.
• Excellent written and verbal communication.
• Independent worker with remote work capability.

Responsibilities

• Collect, process, and evaluate adverse event reports from various sources.
• Ensure timely and accurate reporting of safety data to regulatory agencies worldwide.
• Conduct medical assessment of adverse events and determine causality.
• Maintain and manage the pharmacovigilance database.
• Contribute to PSURs and RMPs and other safety documents.
• Liaise with internal and external stakeholders on safety matters.

Skills

Medical terminology

Analytical skills

Communication skills

Remote work

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Nursing

Bachelor's degree in Life Sciences

Tools

MS Office

Job description

About the Role

Our client, a renowned pharmaceutical company, is seeking a dedicated and vigilant Pharmacovigilance Specialist to join their expanding safety monitoring team. This fully remote role is critical for ensuring the ongoing safety of our marketed pharmaceutical products and investigational drugs. You will be responsible for the collection, assessment, and reporting of adverse event data to regulatory authorities. This position requires a meticulous individual with a strong understanding of pharmacovigilance principles and a commitment to patient safety. The successful candidate will contribute significantly to maintaining regulatory compliance and safeguarding public health from the convenience of their remote workspace.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources.
• Ensure timely and accurate reporting of safety data to regulatory agencies worldwide.
• Conduct medical assessment of adverse events and determine causality.
• Maintain and manage the pharmacovigilance database.
• Contribute to the preparation of safety documents, such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Liaise with internal departments (e.g., Clinical, Medical Affairs) and external stakeholders on safety matters.
• Stay updated on global pharmacovigilance regulations and guidelines.
• Participate in safety surveillance activities and signal detection.
• Contribute to the development and maintenance of Standard Operating Procedures (SOPs) for pharmacovigilance.
• Ensure compliance with all relevant pharmacovigilance requirements.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Thorough understanding of global pharmacovigilance regulations (e.g., ICH guidelines, GVP modules).
• Experience with adverse event reporting systems and pharmacovigilance databases.
• Strong medical terminology and analytical skills.
• Excellent written and verbal communication skills.
• High level of attention to detail and accuracy.
• Ability to work independently and manage multiple tasks effectively in a remote setting.
• Proficiency in relevant software, including MS Office.
• Problem-solving abilities and a proactive approach to safety issues.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health insurance, retirement plan contributions, and performance-based incentives. As a fully remote position, we provide support for setting up a productive home office and offer flexible working hours. Employees benefit from opportunities for professional development, including specialized pharmacovigilance training and certification support. Our client is committed to fostering a culture of continuous improvement and professional growth, ensuring ample opportunities for career advancement within the field of drug safety and regulatory compliance.