Drug Safety Physician

Placements24; Pretoria; Ibrido; ZAR 1.200.000 - 1.800.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension fund contributions

Health & disability insurance

International exposure

Professional growth opportunities

Descrizione del lavoro

Placements24 in Pretoria is seeking a qualified Drug Safety Physician to join its pharmacovigilance team. The role involves assessment, management, and reporting of adverse events for marketed and investigational products.

You will collaborate closely with regulatory affairs, clinical development, and medical affairs to ensure patient safety and regulatory compliance. MBChB or equivalent with 5+ years in pharmacovigilance is required, along with strong safety reporting knowledge.

Competenze

• Medical degree MBChB or equivalent and valid medical license.
• At least 5 years of pharmacovigilance or drug safety experience.
• Strong knowledge of global regulatory requirements for pharmacovigilance.
• Experience with safety databases and reporting tools.
• Excellent medical judgment and communication abilities.

Mansioni

• Evaluate and assess individual case safety reports (ICSRs) for seriousness, causality, and expectedness.
• Ensure timely and accurate submission of safety reports to regulatory authorities worldwide.
• Contribute to the development and review of periodic safety update reports (PSURs/PBRERs) and risk management plans (RMPs).
• Provide medical input on safety-related aspects of clinical trial protocols and investigator brochures.
• Collaborate with cross-functional teams to address safety signals and implement risk mitigation strategies.

Conoscenze

Medical knowledge

Analytical skills

Communication

Formazione

MBChB or equivalent

Strumenti

Safety databases

Descrizione del lavoro

About the Role

Our client is seeking a qualified and experienced Drug Safety Physician to join their pharmacovigilance team based in Pretoria . This critical role involves the assessment, management, and reporting of adverse events associated with marketed pharmaceutical products and investigational drugs. You will work closely with regulatory affairs, clinical development, and medical affairs teams to ensure patient safety and regulatory compliance. The ideal candidate will possess strong medical knowledge, a keen understanding of safety reporting requirements, and a commitment to safeguarding public health through rigorous pharmacovigilance practices within a reputable organization in Pretoria .

Key Responsibilities

• Evaluate and assess individual case safety reports (ICSRs) for seriousness, causality, and expectedness.


• Ensure timely and accurate submission of safety reports to regulatory authorities worldwide.


• Contribute to the development and review of periodic safety update reports (PSURs/PBRERs) and risk management plans (RMPs).


• Provide medical input on safety-related aspects of clinical trial protocols and investigator brochures.


• Collaborate with cross-functional teams to address safety signals and implement risk mitigation strategies.

Requirements

• Medical Doctor (MBChB or equivalent) with a valid medical license.


• Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.


• In-depth knowledge of global regulatory requirements for pharmacovigilance and adverse event reporting.


• Experience with safety databases and reporting tools.


• Excellent medical judgment, analytical skills, and strong written and verbal communication abilities.

Benefits

• Highly attractive salary commensurate with experience.


• Comprehensive health, disability, and life insurance coverage.


• Pension fund contributions and other retirement benefits.


• Significant opportunities for professional growth and international exposure.


• A collaborative and intellectually stimulating work environment in Pretoria .