Pharmacovigilance Specialist: Drug Safety & Signal Analyst

Placements24; Polokwane; Sur place; ZAR 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement contributions

Life assurance

Generous annual leave

Résumé du poste

Placements24 in Polokwane, Limpopo, ZA, seeks a Pharmacovigilance Specialist to monitor drug safety, collect and assess AE data, and ensure regulatory compliance. You will manage safety reporting, PSURs, and safety communications while collaborating with Medical Affairs, Regulatory, and Clinical teams.

The role emphasizes accuracy, timely reporting, and staying current with ICH PV guidelines in a fast-paced environment. A healthcare degree and PV experience are essential.

Qualifications

• Strong analytical and critical thinking skills.
• Excellent attention to detail and accuracy in data handling and reporting.
• Good written and verbal communication skills.
• Proficiency in Microsoft Office Suite.
• Experience with pharmacovigilance databases and safety reporting systems.

Responsabilités

• Collect, assess, and document adverse event reports from various sources.
• Ensure accurate and timely reporting of adverse events to regulatory authorities and internal stakeholders.
• Maintain and update the pharmacovigilance database with all relevant safety information.
• Participate in signal detection and risk assessment activities.
• Contribute to the preparation of PSURs and other safety documents.
• Collaborate with Medical Affairs, Clinical Operations and Regulatory Affairs on safety matters.
• Ensure compliance with pharmacovigilance regulations and SOPs.
• Stay updated on global PV guidelines and best practices.
• Assist in developing PV training programs.
• Respond to safety inquiries from regulatory authorities and business partners.

Connaissances

Analytical thinking

Attention to detail

Communication skills

Office software

PV databases knowledge

Formation

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

Description du poste

Placements24 in Polokwane, Limpopo, ZA, seeks a Pharmacovigilance Specialist to monitor drug safety, collect and assess AE data, and ensure regulatory compliance. You will manage safety reporting, PSURs, and safety communications while collaborating with Medical Affairs, Regulatory, and Clinical teams.

The role emphasizes accuracy, timely reporting, and staying current with ICH PV guidelines in a fast-paced environment. A healthcare degree and PV experience are essential.