Senior Pharmacovigilance Specialist (Remote)

Placements24; Queenstown; Hybrid; NZD 100,000 - 180,000; Full time

Benefits offered by this job

Competitive salary

Bonus program

Health insurance

Retirement plan with company match

Flexible PTO

Professional development

Remote work

Home office stipend

Certifications support

Impactful work

Job summary

Placements24 is seeking a Senior Pharmacovigilance Specialist to join a global, remote-first safety surveillance team. You will manage adverse event reports, evaluate causality, and prepare regulatory safety submissions to authorities worldwide, ensuring compliance across markets.

The role requires 5–7 years PV experience, strong knowledge of FDA/EMA/CIOMS regulations, and proficiency with Argus/ArisG. You will mentor junior staff and collaborate cross-functionally in a flexible, remote

Qualifications

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related field.
• 5–7 years hands-on pharmacovigilance/drug safety experience.
• Strong knowledge of global pharmacovigilance regulations (FDA/EMA/CIOMS).
• Experience with safety databases (Argus/ArisG) and case processing.
• Proficiency in AE data analysis and reporting.
• Excellent written and verbal communication with meticulous attention to detail.
• Ability to work independently in a remote setting and collaborate cross-functionally.
• Experience in signal detection and risk management is desirable.

Responsibilities

• Manage and process adverse event reports from various sources with timely data entry.
• Perform case assessments including causality and seriousness determinations.
• Prepare and submit regulatory safety reports (SUSARs, DSURs) to health authorities.
• Collaborate with Clinical Operations, Medical Affairs, and external partners for safety information.
• Contribute to pharmacovigilance SOPs, training materials, and risk management plans.
• Engage in signal detection activities for further investigation.
• Support regulatory inspections and internal pharmacovigilance audits.
• Stay updated with global PV regulations and best practices.
• Mentor junior PV staff and contribute to aggregate safety reports.

Skills

Pharmacovigilance

Adverse event analysis

Case processing

Signal detection

SOP development

Cross-functional collaboration

Remote work

Regulatory compliance

Education

Bachelor’s in Pharmacy/Life Sciences

Advanced degree (plus)

Tools

Argus

ArisG

Job description

About the Role

Our client, a leading global pharmaceutical company, is seeking a highly experienced Senior Pharmacovigilance Specialist to join their fully remote safety surveillance team. This position is critical for ensuring the ongoing safety monitoring of our pharmaceutical products worldwide. You will be responsible for the collection, assessment, and reporting of adverse event data, ensuring compliance with all global regulatory requirements. As a remote-first organization, we empower our team members with the autonomy and resources needed to perform their roles effectively from anywhere. This is an exceptional opportunity for a dedicated professional to contribute to patient safety on a global scale while enjoying the benefits of a flexible, remote work environment. We are committed to fostering a culture of safety, collaboration, and continuous improvement. The ideal candidate will possess extensive knowledge of pharmacovigilance principles, strong analytical skills, and the ability to manage complex safety data with precision. Embrace a career where your expertise directly contributes to safeguarding public health.

Key Responsibilities

• Manage and process adverse event reports from various sources, ensuring timely and accurate data entry into safety databases.
• Perform case assessments, including causality evaluation and seriousness determination, in accordance with company and regulatory guidelines.
• Prepare and submit regulatory safety reports (e.g., SUSARs, DSURs) to health authorities globally.
• Collaborate with internal departments (e.g., Clinical Operations, Medical Affairs) and external partners to gather necessary safety information.
• Contribute to the development and maintenance of pharmacovigilance SOPs, training materials, and risk management plans.
• Participate in signal detection activities, identifying potential safety signals for further investigation.
• Support regulatory inspections and internal audits related to pharmacovigilance compliance.
• Stay current with global pharmacovigilance regulations, guidelines, and best practices.
• Mentor and provide guidance to junior pharmacovigilance staff.
• Contribute to aggregate safety reports and risk-benefit assessments.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field. Advanced degree is a plus.
• Minimum of 5-7 years of hands-on experience in pharmacovigilance and drug safety.
• Thorough understanding of global pharmacovigilance regulations (e.g., FDA, EMA, CIOMS).
• Experience with safety databases (e.g., Argus, ArisG) and case processing.
• Proficiency in adverse event data analysis and reporting.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent written and verbal communication skills, with meticulous attention to detail.
• Ability to work independently and manage workload effectively in a remote setting.
• Proven ability to collaborate effectively with cross-functional teams.
• Experience in signal detection and risk management is highly desirable.

Benefits

• Highly competitive salary and performance-based bonus.
• Comprehensive health, dental, and vision insurance plans.
• Generous retirement savings plan with company match.
• Flexible paid time off and holiday schedule.
• Opportunities for professional development and continuing education.
• Access to advanced safety surveillance systems and technologies.
• A supportive and collaborative remote working environment.
• Home office stipend to ensure optimal work setup.
• Contribution towards professional certifications and conferences.
• Meaningful work that directly impacts patient safety worldwide.