Senior Pharmacovigilance Scientist

Placements24; Pretoria; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Pension benefits

Training opportunities

Hybrid work in Pretoria

Job summary

Placements24 is seeking a Senior Pharmacovigilance Scientist to strengthen its safety monitoring team in Pretoria. The role involves assessing and reporting adverse events linked to pharmaceutical products, ensuring patient safety and regulatory compliance.

You'll contribute to signal detection, risk management, and PSUR preparation while collaborating with clinical, medical, and regulatory colleagues. A proactive scientist with PV experience will thrive in this organization.

Qualifications

• Degree in Pharmacy, Medicine, Nursing, or life sciences.
• Minimum 5 years in pharmacovigilance or drug safety.
• Proficiency with adverse event case processing and safety databases.
• Strong knowledge of global PV regulations.

Responsibilities

• Collect, assess, and document adverse event reports.
• Perform case processing and regulatory reporting of SAEs.
• Contribute to signal detection and safety trend evaluation.
• Prepare PSURs and other regulatory safety submissions.
• Collaborate with clinical, medical, and regulatory teams on safety info.
• Stay updated on global pharmacovigilance regulations.

Skills

Pharmacovigilance

Adverse event processing

Signal detection

Regulatory reporting

Data analysis

Education

Pharmacy/Medicine/Nursing degree

Tools

Argus

ArisG

Job description

Our client, a prominent pharmaceutical entity, is actively seeking a skilled Senior Pharmacovigilance Scientist to enhance their safety monitoring team in Pretoria . This critical role involves the meticulous assessment and reporting of adverse events associated with their pharmaceutical products, ensuring patient safety and regulatory compliance. You will play a key part in signal detection, risk management, and contributing to the overall safety profile of marketed drugs and investigational products. This position is ideal for a proactive scientist dedicated to patient safety and looking to contribute to pharmacovigilance excellence within a respected organization.

Key Responsibilities

• Collect, assess, and document adverse event reports from various sources, ensuring accuracy and completeness.
• Perform detailed case processing and narrative writing for regulatory reporting of serious adverse events.
• Contribute to signal detection and evaluation activities, identifying potential safety trends or concerns.
• Prepare periodic safety update reports (PSURs) and other regulatory safety submissions.
• Collaborate with clinical, medical, and regulatory affairs teams to manage product safety information.
• Stay abreast of global pharmacovigilance regulations and guidelines, ensuring compliance.

Requirements

• Degree in Pharmacy, Medicine, Nursing, or a related life science field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety.
• Proficiency in adverse event case processing and safety database utilization (e.g., Argus, ArisG).
• Strong understanding of global pharmacovigilance regulations and reporting requirements.
• Excellent analytical, critical thinking, and problem-solving skills.
• Effective written and verbal communication abilities.

Benefits

• Competitive annual salary with performance-based rewards.
• Comprehensive health, disability, and life insurance coverage.
• Pension fund and other retirement benefits.
• Support for continuous professional development and training programs.
• Flexible hybrid work arrangement based in Pretoria .