Remote Senior PV Specialist - Patient Safety Lead

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

Benefits offered by this job

Health insurance

Retirement planning

Home office stipend

Continuous professional development

Performance-based bonuses

Job summary

Placements24 is assisting a global pharmaceutical company in finding a Senior Pharmacovigilance Specialist for a fully remote role in South Africa. You will lead adverse event processing, causality assessment, and regulatory reporting to global authorities, ensuring timelines are met.

You will collaborate with cross-functional teams and maintain PV systems, staying current with ICH guidelines and MedDRA terminology, while contributing to safety signal detection and PSURs from a remote setting.

Qualifications

• Bachelor’s degree in Pharmacy, Medicine, Nursing or related field.
• Master’s degree or equivalent advanced qualification preferred.
• Minimum 5 years in pharmacovigilance with AE processing and regulatory reporting.
• Solid knowledge of global PV regulations and guidelines (ICH E2A, E2B, E2C).
• Experience with safety databases (Argus, ArisG) and case processing.
• Strong medical assessment and data evaluation skills.
• Excellent written and verbal communication; meticulous attention to detail.
• Ability to work independently in a remote setting and manage multiple priorities.

Responsibilities

• Manage and process adverse event reports from various sources.
• Conduct medical assessment of adverse events, including causality and seriousness.
• Ensure timely safety reports to regulatory authorities and internal stakeholders.
• Maintain and update PV database with accurate AE information.
• Participate in signal detection activities and evaluate potential safety signals.
• Collaborate with cross-functional teams on safety matters.
• Assist in PSURs and other regulatory safety documents.
• Contribute to development and maintenance of PV SOPs and training materials.
• Stay current with global PV regulations and best practices.
• Support audits and inspections related to PV activities.

Skills

Pharmacovigilance

Adverse event processing

Regulatory reporting

Medical assessment

Analytical thinking

Communication skills

Independent work

MedDRA

Global PV knowledge

Education

Bachelor's degree in Pharmacy/Medicine/Nursing

Master's degree preferred

Tools

Argus

ArisG

MedDRA

Job description

Placements24 is assisting a global pharmaceutical company in finding a Senior Pharmacovigilance Specialist for a fully remote role in South Africa. You will lead adverse event processing, causality assessment, and regulatory reporting to global authorities, ensuring timelines are met.

You will collaborate with cross-functional teams and maintain PV systems, staying current with ICH guidelines and MedDRA terminology, while contributing to safety signal detection and PSURs from a remote setting.