Lead Pharmacovigilance Specialist

Placements24; Randburg; Hybrid; ZAR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Competitive salary package

Annual bonus based on performance

Medical, pension, and life cover

Generous leave and sick leave

Professional development opportunities

Dynamic Randburg-based workplace

Job summary

Placements24 is seeking an experienced Lead Pharmacovigilance Specialist in Randburg, Gauteng. You will lead a PV team, manage safety databases, and ensure compliance with global regulations for our pharmaceutical products.

You will oversee adverse event data collection, signal detection, and PSUR submissions, while training junior staff and coordinating with authorities and healthcare professionals.

Qualifications

• Bachelor's degree in Pharmacy, Medicine, Nursing, or a related life science field.
• Master's degree is preferred.
• Minimum 7 years in pharmacovigilance with at least 2 years in a lead/supervisory role.
• Solid knowledge of global PV regulations (ICH E2, GVP).
• Experience with PV databases such as Argus/ARISg.

Responsibilities

• Lead and manage PV activities for assigned products in line with regulations.
• Oversee collection, assessment and reporting of adverse events from multiple sources.
• Manage PV database ensuring data integrity and accuracy.
• Conduct signal detection and risk assessment activities.
• Prepare PSURs and other regulatory safety reports.
• Develop and implement PV SOPs and work instructions.
• Train and mentor junior PV staff.
• Liaise with regulators, HCPs, and internal departments on safety matters.
• Ensure PV activities meet global standards and participate in audits.

Skills

Pharmacovigilance leadership

Regulatory compliance

PSUR reporting

Data analysis

Team management

Education

Bachelor's in Pharmacy/Medicine/Nursing

Master's degree preferred

Tools

Argus

ARISg

Job description

About the Role

Our client, a global pharmaceutical company with a significant presence in Randburg, Gauteng , is looking for an experienced and proactive Lead Pharmacovigilance Specialist. This role is essential for ensuring the safety of our pharmaceutical products by monitoring, collecting, and reporting adverse event data. You will lead a team of specialists, manage safety databases, and ensure compliance with national and international pharmacovigilance regulations. The ideal candidate will have a strong understanding of drug safety principles and regulatory requirements, coupled with excellent leadership and analytical skills. This is a challenging and rewarding opportunity to contribute to patient safety and public health from our offices in Randburg .

Key Responsibilities

• Lead and manage the pharmacovigilance activities for assigned products, ensuring compliance with all applicable regulations.
• Oversee the collection, assessment, and reporting of adverse event data from various sources.
• Manage the pharmacovigilance database, ensuring data integrity and accuracy.
• Conduct signal detection and risk assessment activities to identify potential safety issues.
• Prepare and submit Periodic Safety Update Reports (PSURs) and other regulatory safety reports.
• Develop and implement pharmacovigilance Standard Operating Procedures (SOPs) and work instructions.
• Train and mentor junior pharmacovigilance staff.
• Liaise with regulatory authorities, healthcare professionals, and internal departments on safety matters.
• Ensure that all pharmacovigilance activities conducted for products available in or near Randburg meet the highest global standards.
• Participate in audits and inspections related to pharmacovigilance compliance.

Requirements

• Bachelor's degree in Pharmacy, Medicine, Nursing, or a related life science field.
• A Master's degree is preferred.
• Minimum of 7 years of experience in pharmacovigilance, with at least 2 years in a lead or supervisory role.
• In-depth knowledge of global pharmacovigilance regulations (e.g., ICH E2 series, GVP modules) and reporting requirements.
• Experience with pharmacovigilance databases (e.g., Argus, ARISg) and case processing.
• Strong analytical skills for signal detection and risk assessment.
• Excellent written and verbal communication skills, with the ability to present complex safety information clearly.
• Proven leadership and team management capabilities.
• Ability to work independently and manage multiple priorities effectively.
• Commitment to ensuring patient safety and data integrity within the Randburg context.

Benefits

• Competitive annual salary of ZAR .
• Annual bonus based on performance.
• Comprehensive medical, pension, and life cover.
• Generous annual leave and sick leave.
• Opportunities for professional development and specialized training.
• A dynamic and collaborative work environment in Randburg .