Remote Senior Pharmacovigilance Specialist - Global Safety

Placements24; Sandton; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Remote work

Flexible schedule

Health benefits

Job summary

Placements24 is seeking a Senior Pharmacovigilance Specialist for a fully remote position based in South Africa. You will manage safety data, perform signal detection, and prepare regulatory reports in alignment with GVP and ICH guidelines.

The role emphasizes independence, meticulous data integrity, and collaboration with cross-functional teams. The ideal candidate has 4+ years in PV, experience with Argus/ARISg, and strong communication skills.

Qualifications

• 4+ years of pharmacovigilance experience with AE processing and regulatory reporting.
• Strong knowledge of GVP and ICH guidelines (E2B, E2C).
• Experience with safety databases Argus and ARISg.
• Excellent written and verbal communication; medical terminology.
• Ability to work independently in a remote setting.

Responsibilities

• Manage and process adverse event reports and data entry.
• Perform case assessments including causality and seriousness.
• Conduct signal detection to identify new safety concerns.
• Prepare and submit PBRERs and DSURs to regulators.
• Maintain IBs, RMPs, PSURs and other safety documents.
• Collaborate with cross-functional teams on safety matters.
• Train and mentor junior PV staff.

Skills

Pharmacovigilance

Adverse event processing

Signal detection

Regulatory reporting

Data analysis

Education

Bachelor's degree in Pharmacy

Master's degree in life sciences

Tools

Argus

ARISg

MS Office

Job description

Placements24 is seeking a Senior Pharmacovigilance Specialist for a fully remote position based in South Africa. You will manage safety data, perform signal detection, and prepare regulatory reports in alignment with GVP and ICH guidelines.

The role emphasizes independence, meticulous data integrity, and collaboration with cross-functional teams. The ideal candidate has 4+ years in PV, experience with Argus/ARISg, and strong communication skills.