Remote Pharmacovigilance Specialist

Placements24; Benoni; Híbrido; ZAR 420 000 - 700 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Remote work

Career development

Competitive salary

Resumo da oferta

Placements24 is seeking a Remote Pharmacovigilance Specialist to join a globally recognized pharmaceutical company. You will collect, assess, and report adverse events, ensuring regulatory compliance and data integrity in a fully remote role.

The ideal candidate has a life sciences background, 3+ years in pharmacovigilance, and strong analytical and documentation skills. This position offers flexible work-life balance and global collaboration.

Qualificações

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, Medicine, or related field.
• Minimum 3 years in pharmacovigilance or drug safety monitoring.
• Strong understanding of pharmacovigilance principles and global regulatory requirements.

Responsabilidades

• Collect, process, and document adverse event reports from various sources.
• Assess seriousness and causality of adverse events.
• Ensure timely submission of safety reports to regulatory authorities.
• Maintain pharmacovigilance database with accurate information.
• Collaborate with Medical Affairs, Regulatory, and Clinical Development on safety matters.
• Assist in PSURs and risk management plan preparation.
• Stay updated on global pharmacovigilance regulations and best practices.
• Support audits and inspections related to pharmacovigilance.

Conhecimentos

Pharmacovigilance

Adverse Event Reporting

Regulatory Compliance

Data Entry & Documentation

Remote Collaboration

Formação académica

Bachelor's degree in Pharmacy

Life Sciences background

Ferramentas

Argus

ArisG

Microsoft Office

Descrição da oferta de emprego

About the Role

Our client, a globally recognized pharmaceutical company with a commitment to patient safety, is seeking a detail-oriented and experienced Remote Pharmacovigilance Specialist . This position is crucial for monitoring the safety of our client's pharmaceutical products worldwide. You will be responsible for collecting, assessing, and reporting adverse event data, ensuring compliance with global pharmacovigilance regulations. The ideal candidate will possess a strong background in healthcare or life sciences, a thorough understanding of pharmacovigilance principles and regulatory requirements, and excellent analytical and documentation skills. This is an excellent opportunity to contribute to drug safety and patient well-being from a fully remote work environment, allowing for flexibility and work-life balance.

Key Responsibilities

Collect, process, and document adverse event reports from various sources (e.g., healthcare professionals, patients, literature). Perform initial assessment of reported adverse events for seriousness and causality. Ensure timely and accurate submission of safety reports to regulatory authorities worldwide. Maintain and update the pharmacovigilance database with accurate and complete information. Collaborate with internal teams (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) on safety-related matters. Contribute to the preparation of periodic safety update reports (PSURs) and risk management plans. Stay current with global pharmacovigilance regulations, guidelines, and best practices. Participate in internal and external audits and inspections related to pharmacovigilance. Provide support and training to colleagues on pharmacovigilance processes as needed.

Requirements

Bachelor's degree in Pharmacy, Nursing, Life Sciences, Medicine, or a related field. Minimum of 3 years of experience in pharmacovigilance or drug safety monitoring. Thorough understanding of pharmacovigilance principles, processes, and global regulatory requirements (e.g., FDA, EMA, SAHPRA). Experience with safety databases (e.g., Argus, ArisG) and adverse event reporting systems. Excellent attention to detail, analytical skills, and ability to interpret medical terminology. Strong written and verbal communication skills, essential for remote collaboration and reporting. Ability to work independently, manage time effectively, and meet strict deadlines. Proficiency in Microsoft Office Suite and other relevant software. Commitment to maintaining patient confidentiality and data integrity.

Benefits

This fully remote position offers a competitive salary and a comprehensive benefits package, including excellent medical, dental, and vision insurance, and a robust retirement savings plan. Our client is dedicated to employee growth, providing opportunities for professional development through online training, workshops, and certifications. The flexibility of a remote role allows for a superior work-life balance. Join a leading pharmaceutical organization committed to global patient safety and contribute to a vital function within the industry from the convenience of your home office.