Remote Senior Pharmacovigilance Scientist – SA

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 900.000 - 1.400.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement contributions

Zusammenfassung

Placements24 is seeking a highly skilled Remote Senior Pharmacovigilance Scientist in South Africa. You will oversee safety surveillance for assigned products, perform signal detection, and prepare regulatory safety documents such as PSURs and DSURs.

The role requires 5+ years in pharmacovigilance, deep regulatory knowledge, and the ability to work remotely. You will collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to ensure patient safety and compliant reporting

Qualifikationen

• 5+ years of experience in pharmacovigilance or drug safety.
• Strong understanding of global pharmacovigilance regulations (GVP, FDA, SAHPRA).
• Experience in signal detection, risk assessment and safety reports.
• Excellent written and verbal communication, with ability to present complex data clearly.
• Ability to work independently in a remote setting.

Aufgaben

• Perform safety surveillance for assigned products, including case processing oversight and data analysis.
• Conduct signal detection and evaluation, identify safety issues and assess significance.
• Draft and review PSURs, DSURs, and other regulatory safety documents.
• Contribute to RMPs and REMS development and maintenance.
• Liaise with regulators and ensure timely safety report submissions.
• Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs.
• Review investigator brochures and protocols from a safety perspective in trials.
• Develop and implement pharmacovigilance policies and procedures.
• Interpret safety data from spontaneous reports, literature, and studies.
• Stay updated on global PV regulations and best practices.

Kenntnisse

Pharmacovigilance

Remote work experience

Regulatory reporting

Data analysis

Communication skills

Ausbildung

PharmD, PhD, MSc, MD

Jobbeschreibung

Placements24 is seeking a highly skilled Remote Senior Pharmacovigilance Scientist in South Africa. You will oversee safety surveillance for assigned products, perform signal detection, and prepare regulatory safety documents such as PSURs and DSURs.

The role requires 5+ years in pharmacovigilance, deep regulatory knowledge, and the ability to work remotely. You will collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to ensure patient safety and compliant reporting