Remote Pharmacovigilance Specialist: Drug Safety & Reporting

Placements24; South Africa; A distancia; ZAR 520.000 - 860.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work benefits package

Descripción de la vacante

Placements24, in partnership with a global biopharmaceutical leader, seeks a Remote Pharmacovigilance Specialist to monitor, assess, and report adverse events. This fully remote role enables you to contribute to drug safety from anywhere in South Africa, collaborating with a distributed global team.

The ideal candidate has a Bachelor's in a healthcare field and at least 3 years in pharmacovigilance, with strong knowledge of ICH-GCP, GVP, and MedDRA.

Formación

• Minimum 3 years of experience in pharmacovigilance or drug safety.
• Experience with adverse event case processing and regulatory reporting.
• Strong knowledge of ICH-GCP, GVP guidelines, and regulatory requirements.

Responsabilidades

• Collect, process, and evaluate adverse event reports from various sources.
• Enter data accurately into safety databases.
• Code adverse events using MedDRA or WHO-DD terms.
• Prepare and submit regulatory safety reports within defined timelines.
• Collaborate with internal and external partners to gather case information.
• Support development and maintenance of pharmacovigilance procedures and guidelines.
• Participate in safety surveillance activities and risk management planning.
• Stay updated on global pharmacovigilance regulations.

Conocimientos

Pharmacovigilance

Regulatory reporting

Adverse event processing

ICH-GCP

GVP guidelines

Safety databases

MedDRA/WHO-DD

Remote teamwork

Educación

Bachelor's degree in Pharmacy, Nursing, Life Sciences

Herramientas

Safety databases

Data entry systems

MedDRA/WHO-DD dictionaries

Descripción del empleo

Remote Pharmacovigilance Specialist - Drug Safety

About the Role Our client, a global biopharmaceutical leader committed to improving patient health, is seeking a dedicated Remote Pharmacovigilance Specialist. This fully remote position allows you to contribute to drug safety from anywhere in South Africa. The role involves the meticulous monitoring, assessment, and reporting of adverse events associated with pharmaceutical products. The ideal candidate will possess a strong understanding of pharmacovigilance principles, regulatory requirements, and case processing. This is an exceptional opportunity to join a forward‑thinking company that values work‑life balance and invests in its employees' growth. You will play a critical role in ensuring the safety and efficacy of our client's medicines worldwide, working collaboratively with a distributed global team.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources (healthcare professionals, patients, literature).
• Ensure accurate and timely data entry into safety databases.
• Conduct medical coding of adverse events using standard terminologies (e.g., MedDRA).
• Prepare and submit regulatory safety reports (e.g., SUSARs, periodic safety update reports) within defined timelines.
• Collaborate with internal departments and external partners to gather case information.
• Contribute to the development and maintenance of pharmacovigilance procedures and guidelines.
• Participate in safety surveillance activities and risk management planning.
• Stay updated on global pharmacovigilance regulations and guidelines.
• Assist in the preparation of safety sections for regulatory submissions and clinical study documents.

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.
• Demonstrated experience in adverse event case processing and regulatory reporting.
• Solid understanding of ICH‑GCP, GVP guidelines, and relevant regulatory requirements.
• Proficiency with safety databases and data entry systems.
• Familiarity with medical coding dictionaries (e.g., MedDRA, WHO‑DD).
• Excellent attention to detail, organizational skills, and ability to manage workload effectively.
• Strong written and verbal communication skills.
• Ability to work independently and as part of a remote, global team.

Benefits Our client offers a competitive salary, comprehensive remote work benefits package, and significant opportunities for professional development and career advancement within a global organization. This role provides the flexibility of remote work, allowing for an excellent work‑life balance. Employees are encouraged to engage in continuous learning and are supported in attending relevant industry conferences.