Pharmacovigilance Specialist

Placements24; Newlands; Hybrid; AUD 65,000 - 81,000; Full time

Benefits offered by this job

Competitive salary

Professional development

Health & wellness

Paid time off

Job summary

Placements24 seeks a vigilant Pharmacovigilance Specialist to monitor, assess, and report adverse events, ensuring compliance with SAHPRA, FDA, EMA requirements from our Queenstown office.

You will collect data, conduct literature reviews, contribute to PSURs and RMPs, and liaise with Clinical Operations and Regulatory Affairs to safeguard patient safety and data integrity.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field.
• 2+ years of experience in pharmacovigilance or drug safety.
• Solid understanding of pharmacovigilance principles and regulatory requirements (SAHPRA, FDA, EMA).

Responsibilities

• Collect, document, and assess adverse event reports from various sources.
• Ensure timely and accurate reporting of safety information to regulatory authorities and internal stakeholders.
• Conduct literature reviews to identify potential safety signals and emerging risks.
• Contribute to preparation of PSURs and RMPs.
• Liaise with internal departments and external partners regarding safety matters.

Skills

Pharmacovigilance

Adverse events

Regulatory compliance

Data analysis

Education

Bachelor's degree in health sciences

Tools

Safety databases

Case processing

Job description

Our client is seeking a vigilant and detail-oriented Pharmacovigilance Specialist to contribute to patient safety efforts from their Queenstown office. This role is crucial for monitoring, detecting, and preventing adverse effects associated with pharmaceutical products. You will be responsible for collecting, assessing, and reporting adverse event data, ensuring compliance with global regulatory requirements for drug safety. This position offers a chance to work in a critical area of pharmaceutical development, safeguarding patient well-being and upholding the integrity of medicinal products.

Key Responsibilities

• Collect, document, and assess adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure timely and accurate reporting of safety information to regulatory authorities and internal stakeholders.
• Conduct literature reviews to identify potential safety signals and emerging risks.
• Contribute to the preparation of periodic safety update reports (PSURs) and risk management plans (RMPs).
• Liaise with internal departments (e.g., Clinical Operations, Regulatory Affairs) and external partners regarding safety matters.
• Maintain the pharmacovigilance database and ensure data quality and integrity.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 2 years of experience in pharmacovigilance or drug safety.
• Solid understanding of pharmacovigilance principles, adverse event reporting, and regulatory requirements (e.g., SAHPRA, FDA, EMA).
• Experience with safety databases and case processing.
• Strong analytical skills and the ability to meticulously review and interpret safety data.
• Excellent written and verbal communication skills, with a high degree of accuracy and attention to detail.

Benefits

• Competitive annual salary and benefits package.
• Opportunities for professional development and specialized training in drug safety.
• Comprehensive health and wellness programs.
• Paid time off and company holidays.
• A dedicated team environment focused on patient safety in Queenstown .