Senior Pharmacovigilance Officer

Placements24; Upington; Presencial; ZAR 900.000 - 1.300.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Retirement plan

Career growth

Descripción de la vacante

Placements24 is seeking a Senior Pharmacovigilance Officer for an on-site role in Upington, Northern Cape. The candidate will manage adverse event reports, ensure regulatory compliance, and contribute to ongoing product safety assessments.

The role requires a Bachelor’s degree in a healthcare field and at least four years in pharmacovigilance, with strong data management and analytical skills. On-site work with opportunities for professional growth and safety system improvements.

Formación

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field.
• Minimum of 4 years of experience in pharmacovigilance or drug safety.
• Thorough understanding of global pharmacovigilance regulations (e.g., ICH E2B, E2C) and reporting requirements.
• Proficiency in using safety databases and data management systems.
• Strong medical terminology knowledge and ability to assess adverse event seriousness and causality.
• Excellent analytical, problem-solving, and critical thinking skills.
• Meticulous attention to detail and strong organizational abilities.
• Effective written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.

Responsabilidades

• Receive, process, and evaluate adverse event reports from various sources (healthcare professionals, patients, literature).
• Ensure timely and accurate reporting of adverse events to regulatory authorities worldwide per deadlines.
• Conduct detailed case assessments including causality and seriousness determinations.
• Maintain the global safety database ensuring data integrity.
• Assist in PSURs and regulatory safety documents.
• Monitor safety signals and participate in signal detection activities.
• Collaborate with Clinical Operations, Medical Affairs, Regulatory Affairs on safety matters.
• Assist in development and implementation of pharmacovigilance procedures and SOPs.
• Support regulatory inspections and internal audits related to pharmacovigilance.
• Stay current with evolving pharmacovigilance regulations and guidelines.
• Provide training to junior staff on pharmacovigilance processes.
• Contribute to risk management plans and benefit-risk assessments.

Conocimientos

Analytical skills

Attention to detail

Team collaboration

Independent work

Educación

Bachelor's degree in Pharmacy, Nursing, Life Sciences or related field

Herramientas

Safety databases

Data management systems

Descripción del empleo

About the Role

Our client, a leading pharmaceutical company dedicated to patient safety, is looking for a highly skilled and experienced Senior Pharmacovigilance Officer to join their important safety surveillance team. This role is based in Upington, Northern Cape , and requires an individual with a profound understanding of drug safety principles and regulatory requirements. You will be responsible for managing and processing adverse event reports, ensuring compliance with global safety regulations, and contributing to the ongoing assessment of product safety profiles. The ideal candidate will have a strong background in pharmacovigilance, excellent analytical skills, and meticulous attention to detail. This is a critical on-site role focused on safeguarding public health through robust safety monitoring of pharmaceutical products. We seek a proactive individual committed to maintaining the highest standards of drug safety.

Key Responsibilities

• Receive, 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 worldwide in accordance with applicable deadlines.
• Conduct detailed case assessments, including causality evaluations and seriousness determinations.
• Maintain the global safety database, ensuring data integrity and accuracy.
• Contribute to the preparation and submission of periodic safety update reports (PSURs) and other regulatory safety documents.
• Monitor emerging safety signals and participate in signal detection activities.
• Collaborate with internal departments (e.g., Clinical Operations, Medical Affairs, Regulatory Affairs) on safety-related matters.
• Assist in the development and implementation of pharmacovigilance procedures and SOPs.
• Support regulatory inspections and internal audits related to pharmacovigilance.
• Stay current with evolving global pharmacovigilance regulations and guidelines.
• Provide training and guidance to junior staff on pharmacovigilance processes.
• Contribute to risk management plans and benefit-risk assessments.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 4 years of experience in pharmacovigilance or drug safety.
• Thorough understanding of global pharmacovigilance regulations (e.g., ICH E2B, E2C) and reporting requirements.
• Proficiency in using safety databases and data management systems.
• Strong medical terminology knowledge and ability to assess adverse event seriousness and causality.
• Excellent analytical, problem-solving, and critical thinking skills.
• Meticulous attention to detail and strong organizational abilities.
• Effective written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Experience with medical literature review and signal detection methodologies is a plus.

Benefits

• Our client offers a competitive salary, a comprehensive benefits package including medical, dental, and retirement savings plans, and opportunities for professional growth.

This role in Upington, Northern Cape allows you to play a vital part in ensuring drug safety within a respected pharmaceutical organization. You will contribute directly to patient well-being and work within a supportive team environment. We are committed to the development of our employees and provide resources for continuous learning and career advancement. Join us to make a meaningful contribution to pharmaceutical safety and public health.