Remote Pharmaceutical Pharmacovigilance Specialist

Placements24; Paarl; Hybrid; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Remote work flexibility

Health/dental/vision insurance

Career development opportunities

Work-life balance

Job summary

Placements24 is actively seeking a meticulous Remote Pharmaceutical Pharmacovigilance Specialist to oversee safety monitoring of pharmaceutical products from a fully remote location in South Africa. You will collect, assess, and report adverse events to authorities, ensuring compliance with global PV regulations and maintaining high data quality.

The role requires a Bachelor’s degree in a healthcare field and at least 3 years of PV experience, with strong knowledge of FDA/EMA/ICH GVP and

Qualifications

• 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 (FDA, EMA, ICH GVP).
• Experience with safety databases (Argus, ARISg) is highly desirable.
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Excellent written and verbal communication skills, crucial for effective remote collaboration.

Responsibilities

• Collect, process, and document adverse event reports from various sources according to company procedures and regulatory requirements.
• Assess the seriousness and causality of reported adverse events, ensuring accurate and timely reporting to health authorities.
• Contribute to the preparation and submission of PSURs and other safety-related regulatory documents.
• Participate in signal detection activities, identifying potential new safety concerns.
• Liaise with internal departments and external partners on pharmacovigilance matters.
• Maintain accurate and up-to-date pharmacovigilance databases and records.

Skills

Pharmacovigilance

Data analysis

Remote collaboration

Education

Bachelor's degree in Pharmacy/Life Sciences

Tools

Argus

ARISg

Job description

About the Role

Our client is seeking a meticulous and proactive Remote Pharmaceutical Pharmacovigilance Specialist to contribute to the safety monitoring of our pharmaceutical products. Operating entirely from a remote location, you will be responsible for collecting, assessing, and reporting adverse event data to regulatory authorities, ensuring patient safety and compliance with global pharmacovigilance regulations. This role is critical for maintaining the safety profile of our medicines and requires a detail-oriented individual with a strong understanding of drug safety principles. This fully remote opportunity allows you to make a significant impact from anywhere.

Key Responsibilities

• Collect, process, and document adverse event reports from various sources according to company procedures and regulatory requirements.
• Assess the seriousness and causality of reported adverse events, ensuring accurate and timely reporting to health authorities.
• Contribute to the preparation and submission of Periodic Safety Update Reports (PSURs) and other safety-related regulatory documents.
• Participate in signal detection activities, identifying potential new safety concerns related to company products.
• Liaise with internal departments (e.g., Medical Affairs, Regulatory Affairs) and external partners (e.g., CROs) on pharmacovigilance matters.
• Maintain accurate and up-to-date pharmacovigilance databases and records.

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., FDA, EMA, ICH GVP).
• Experience with safety databases (e.g., Argus, ARISg) is highly desirable.
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent written and verbal communication skills, crucial for effective remote collaboration.

Benefits

• Competitive salary and remote work benefits.
• Fully remote position offering flexibility and work-life balance.
• Comprehensive health, dental, and vision insurance.
• Opportunities for career advancement within pharmacovigilance.
• A commitment to employee well-being and professional development.