Remote Pharmacovigilance Specialist

Placements24; Mossel Bay; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Remote work

Medical aid

Retirement fund

Job summary

Placements24 in South Africa is seeking a Remote Pharmacovigilance Specialist to join a global pharmaceutical safety team. You will monitor worldwide product safety, collect and evaluate adverse events, and ensure regulatory compliance from a home office.

This remote role requires 3–5 years in pharmacovigilance, strong knowledge of ICH guidelines and global regulations, and experience with PV databases. You will collaborate with cross-functional teams to maintain data integrity and timely

Qualifications

• 3–5 years of pharmacovigilance or drug safety experience.
• Thorough knowledge of global PV regulations (FDA, EMA, SAHPRA) and ICH.
• Experience with PV databases and safety reporting systems.
• Strong analytical and communication skills.

Responsibilities

• Collect, process, and evaluate adverse event reports from various sources.
• Ensure timely and accurate reporting of adverse events to authorities and internal stakeholders.
• Maintain PV database data integrity and compliance.
• Participate in signal detection and risk assessment activities.
• Contribute to PSURs and regulatory documents.
• Collaborate with Medical Affairs, Regulatory, and Clinical teams on safety matters.
• Assist in PV procedures and training materials.
• Conduct literature reviews for safety signals and trends.
• Ensure compliance with PV regulations and guidelines.
• Support audits and inspections related to PV activities.

Skills

Pharmacovigilance

Adverse event reporting

Regulatory compliance

PSUR preparation

Data entry

Education

Bachelor's degree in a healthcare field

Tools

Argus

ARISg

Job description

About the Role

Our client, a leading global pharmaceutical company, is seeking a diligent and experienced Remote Pharmacovigilance Specialist to join their dedicated safety surveillance team. This role is crucial for monitoring the safety profile of our client's pharmaceutical products worldwide, ensuring patient safety and regulatory compliance. As a remote-first position, you will have the flexibility to work from anywhere within South Africa, contributing to critical pharmacovigilance activities from the comfort of your home office. This is an excellent opportunity to be part of a forward-thinking organization committed to ethical drug safety practices and innovation in patient care. You will play a vital role in the post-marketing surveillance of pharmaceutical products, helping to safeguard public health.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure timely and accurate reporting of adverse events to regulatory authorities and internal stakeholders.
• Maintain the pharmacovigilance database, ensuring data integrity and compliance.
• Participate in signal detection and risk assessment activities.
• Contribute to the preparation of periodic safety update reports (PSURs) and other regulatory documents.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) on safety-related matters.
• Assist in the development and implementation of pharmacovigilance procedures and training materials.
• Conduct literature reviews for safety signals and emerging trends.
• Ensure compliance with global pharmacovigilance regulations and guidelines.
• Support audits and inspections related to pharmacovigilance activities.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field.
• Minimum of 3-5 years of experience in pharmacovigilance or drug safety.
• Thorough knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, SAHPRA) and ICH guidelines.
• Experience with pharmacovigilance databases and safety reporting systems (e.g., Argus, ARISg).
• Strong analytical skills and attention to detail for accurate data assessment and reporting.
• Excellent written and verbal communication skills.
• Proven ability to work independently and manage workload effectively in a remote setting.
• Proficiency in Microsoft Office Suite and database management.
• Ability to collaborate effectively with geographically dispersed teams.

Benefits

This fully remote role offers a competitive salary, performance bonuses, and a comprehensive benefits package including medical aid, life insurance, and a retirement fund. You will benefit from the flexibility and autonomy of working from home, with a supportive team environment. Our client invests in employee development, offering continuous learning opportunities and access to relevant training. Join a global leader in pharmaceutical safety and contribute to protecting public health from anywhere in South Africa. This role offers a significant opportunity to advance your career in pharmacovigilance.