Senior Pharmaceutical Pharmacovigilance Specialist

Placements24; LegKraal Gate; Sur place; ZAR 900 000 - 1 200 000; Plein temps

Avantages offerts par ce poste

Medical aid

Retirement fund contributions

Professional development

Résumé du poste

Placements24 is seeking a meticulous Senior Pharmaceutical Pharmacovigilance Specialist to join the safety surveillance team in Mahikeng, North West. You will manage adverse event reports, assess causality and severity, and ensure regulatory submissions align with GVP and ICH E2B guidelines.

You will maintain the PV database, contribute to PSURs and safety documentation, and liaise with healthcare professionals and authorities.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences or related healthcare field.
• Minimum of 4 years' experience in pharmacovigilance or drug safety.
• Solid understanding of pharmacovigilance principles, processes and regulatory requirements (GVP, ICH E2B).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical and organizational skills; attention to detail.
• Excellent written and verbal communication abilities.
• Ability to work independently and in a team.
• Must work on-site in Mahikeng, North West.

Responsabilités

• Collect, process and document adverse event reports from multiple sources.
• Assess case narratives for completeness and accuracy.
• Determine case causality and severity.
• Ensure timely submission of safety reports to authorities and stakeholders.
• Maintain the pharmacovigilance database.
• Contribute to safety documents and PSURs.
• Conduct literature reviews for potential safety signals.
• Liaise with healthcare professionals and regulators on safety matters.
• Stay updated with global pharmacovigilance regulations.

Connaissances

Analytical skills

Attention to detail

Communication skills

Teamwork

Medical terminology

Formation

Bachelors degree in Pharmacy/Nursing/Life Sciences

Outils

Safety databases

Adverse event reporting systems

Description du poste

About the Role

A reputable pharmaceutical company is looking for a meticulous and dedicated Senior Pharmaceutical Pharmacovigilance Specialist to join their safety surveillance team. This critical role, based in Mahikeng, North West , involves the comprehensive management and reporting of adverse events and drug safety information to ensure patient safety and regulatory compliance. The specialist will play a key role in monitoring the safety profile of pharmaceutical products throughout their lifecycle. This is an excellent opportunity to contribute to patient safety within a dynamic and growing organization. Your vigilance will help protect public health.

Key Responsibilities

• Collect, process, and document adverse event reports from various sources.
• Assess case narratives for completeness and accuracy.
• Determine case causality and severity.
• Ensure timely and accurate submission of safety reports to regulatory authorities and internal stakeholders.
• Maintain the pharmacovigilance database.
• Participate in the development and review of safety documents, such as the Investigator's Brochure and Risk Management Plans.
• Conduct literature reviews for potential safety signals.
• Liaise with healthcare professionals, regulatory authorities, and internal departments on safety matters.
• Contribute to the preparation of Periodic Safety Update Reports (PSURs).
• Stay up-to-date with global pharmacovigilance regulations and guidelines.

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.
• Solid understanding of pharmacovigilance principles, processes, and regulatory requirements (e.g., GVP, ICH E2B).
• Experience with safety databases and adverse event reporting systems.
• Strong analytical, organizational, and attention-to-detail skills.
• Excellent written and verbal communication abilities.
• Ability to work independently and as part of a team.
• Proficiency in medical terminology.
• Experience in signal detection and risk assessment is a plus.
• Must be able to work on-site in Mahikeng, North West .

Benefits

This position offers a competitive salary and benefits package, including medical aid, retirement fund contributions, and opportunities for professional development in pharmacovigilance. The role provides a stable work environment in Mahikeng, North West , where you can build a rewarding career focused on patient safety. Join a company that values dedication and scientific integrity.