Remote Principal Pharmacovigilance Specialist

Placements24; Durban; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Home office stipend

Professional development

Job summary

Placements24 is seeking a Principal Pharmacovigilance Specialist to lead safety surveillance for marketed products and trials. This fully remote role supports global regulatory compliance while based in Durban, SA, enabling flexible work-life balance and a strong focus on patient safety.

The candidate will oversee adverse event processing, signal detection, and regulatory reporting, collaborating with Clinical Operations, Regulatory Affairs, and Medical Affairs.

Qualifications

• Advanced degree in pharmacy, life sciences, or medicine with pharmacovigilance knowledge.
• At least 7 years of progressive PV experience in pharma or biotech.
• Strong understanding of global PV regulations and safety reporting standards.
• Excellent written and verbal communication, including reports and audits.
• Ability to work independently in a remote setting with strong prioritization.

Responsibilities

• Oversee adverse event processing from multiple sources with accuracy and completeness.
• Perform signal detection and safety data analyses to identify emerging risks.
• Prepare and submit PSURs, DSURs, and other regulatory safety reports.
• Develop PV policies, procedures, and staff training programs.
• Collaborate with Clinical Ops, Regulatory, Medical to ensure timely safety info exchange.
• Support regulatory inspections and provide documentation as needed.
• Contribute to Investigator Brochures and Clinical Study Reports safety sections.
• Monitor global PV regulatory changes and advise stakeholders.
• Provide expert safety guidance for assigned products.
• Maintain PV databases ensuring data integrity and compliance.

Skills

Pharmacovigilance

Signal detection

Regulatory reporting

Data analysis

Communication skills

Education

Master's degree or PharmD

Tools

Pharmacovigilance databases

Safety reporting software

Job description

Placements24 is seeking a Principal Pharmacovigilance Specialist to lead safety surveillance for marketed products and trials. This fully remote role supports global regulatory compliance while based in Durban, SA, enabling flexible work-life balance and a strong focus on patient safety.

The candidate will oversee adverse event processing, signal detection, and regulatory reporting, collaborating with Clinical Operations, Regulatory Affairs, and Medical Affairs.