Senior Pharmacovigilance Specialist

Placements24; Upington; Híbrido; ZAR 900.000 - 1.500.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental insurance

Vision insurance

Retirement plan with company match

Generous paid time off

Descripción de la vacante

Placements24 seeks a Senior Pharmacovigilance Specialist to enhance drug safety monitoring, data review, and regulatory reporting. The role focuses on collecting and assessing adverse event data, maintaining safety databases, and supporting ongoing clinical development in a hybrid Upington office.

The candidate will lead signal detection, PSURs, and DSURs, ensuring compliance with GVP guidelines and global reporting requirements, while collaborating with cross-functional teams.

Formación

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences or related healthcare field is required.
• Master’s degree or relevant certification is advantageous.
• Minimum of 5 years of progressive experience in pharmacovigilance and regulatory compliance.
• Experience with safety databases and case processing (Argus/ARISg) is preferred.

Responsabilidades

• Process, assess, and manage adverse event reports from various sources.
• Ensure timely and accurate reporting of adverse events to regulators and ethics committees.
• Contribute to PSURs, PADERs, and DSURs.
• Collaborate with clinical operations, regulatory, and medical affairs on safety matters.
• Develop and maintain pharmacovigilance SOPs and training materials.
• Assist in regulatory inspections and audits related to pharmacovigilance.

Conocimientos

Adverse event reporting

Signal detection

Analytical thinking

Cross-functional collaboration

Documentation

Educación

Bachelor's degree in Pharmacy, Nursing, Life Sciences or related field

Master's degree (advantageous)

Herramientas

Argus

ARISg

MS Office

Descripción del empleo

About the Role

Our client, a globally recognized pharmaceutical company dedicated to patient safety, is seeking an experienced Senior Pharmacovigilance Specialist to enhance their drug safety monitoring capabilities. This critical role involves the meticulous collection, assessment, and reporting of adverse event data to ensure compliance with global regulatory requirements. You will play a key part in maintaining the safety profile of marketed products and supporting ongoing clinical development. The position is based at our modern offices in Upington, Northern Cape, within a supportive and scientifically driven team. This hybrid role offers a balanced approach to pharmacovigilance work, combining essential data review and analysis with flexible remote collaboration. We are committed to proactive safety surveillance and robust risk management.

Key Responsibilities

• Process, assess, and manage adverse event reports from various sources (e.g., spontaneous, clinical trials, literature).
• Ensure timely and accurate reporting of adverse events to regulatory authorities and ethics committees worldwide.
• Conduct signal detection and evaluation activities to identify potential new safety concerns.
• Contribute to the preparation of periodic safety update reports (PSURs), PADERs, and DSURs.
• Collaborate with clinical operations, regulatory affairs, and medical affairs teams on safety-related matters.
• Participate in the development and maintenance of pharmacovigilance SOPs and training materials.
• Ensure compliance with global pharmacovigilance regulations and guidelines (e.g., GVP, CIOMS).
• Assist in regulatory inspections and audits related to pharmacovigilance activities.
• Provide safety-related training to internal staff and external partners.
• Maintain databases and records related to adverse event reporting and safety surveillance.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• A Master's degree or relevant certification is advantageous.
• Minimum of 5 years of progressive experience in pharmacovigilance, with a strong understanding of adverse event reporting and regulatory compliance.
• Proven experience in processing and reporting adverse events in accordance with global guidelines.
• In-depth knowledge of global pharmacovigilance regulations and reporting requirements.
• Experience with safety databases (e.g., Argus, ARISg) and case processing.
• Strong analytical and critical thinking skills for signal detection and risk assessment.
• Excellent written and verbal communication skills, with the ability to clearly document complex safety information.
• Proficiency in using Microsoft Office Suite, particularly Word, Excel, and PowerPoint.
• Ability to work independently and collaboratively within a cross-functional team.
• High level of accuracy and attention to detail.

Benefits

• Competitive salary commensurate with experience and qualifications.
• Comprehensive health, dental, and vision insurance coverage.
• Retirement savings plan with company match.
• Generous paid time off and holiday allowance.
• Opportunities for professional development and continuous learning.
• A collaborative and patient-focused work environment.
• Potential for flexible working arrangements.
• Support for ongoing professional certifications.