Senior Pharmacovigilance Officer

Placements24; Polokwane; Presencial; ZAR 750.000 - 1.100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation

Health benefits

Retirement plan

Annual bonus

Professional development

Descripción de la vacante

Placements24 is recruiting a Senior Pharmacovigilance Officer for a client in Polokwane, Limpopo. The role centers on collecting, assessing, and reporting adverse events, maintaining PV systems, and ensuring timely, compliant regulatory submissions for all marketed products.

The ideal candidate will have 5+ years in pharmacovigilance, strong knowledge of global regulations, experience with Argus or ArisG, and a proven ability to mentor junior PV staff within a collaborative team.

Formación

• Bachelor's degree in Pharmacy/Medicine/Nursing or related field.
• Minimum of 5 years in pharmacovigilance, drug safety, or related regulatory function.
• In-depth knowledge of global pharmacovigilance regulations (GVP, FDA, SAHPRA).
• Experience with safety databases (Argus, ArisG) and case processing.
• Strong analytical skills and attention to detail.
• Excellent written and verbal communication, including regulatory reporting.

Responsabilidades

• Oversee collection, processing, and assessment of adverse event reports from all sources.
• Ensure timely and accurate reporting of adverse events to regulatory authorities.
• Conduct signal detection to identify new safety concerns for company products.
• Maintain safety database documentation and ensure data quality.
• Collaborate with Medical Affairs, Regulatory Affairs, and Clinical Development on safety matters.
• Contribute to development and updating of Risk Management Plans and RBAs.
• Participate in regulatory inspections and audits of pharmacovigilance activities.
• Stay updated on global pharmacovigilance regulations and guidelines.

Conocimientos

Pharmacovigilance

Regulatory reporting

Analytical skills

Communication skills

Independent work

Educación

Bachelor's degree in Pharmacy/Medicine/Nursing

Herramientas

Argus

ArisG

Descripción del empleo

About the Role

Our client, a rapidly expanding pharmaceutical company, is seeking a highly competent Senior Pharmacovigilance Officer to enhance their safety surveillance team in Polokwane, Limpopo. This pivotal role involves safeguarding public health by ensuring the timely and accurate collection, assessment, and reporting of adverse event data for all marketed products. The successful candidate will be responsible for maintaining the pharmacovigilance system, conducting signal detection, and managing regulatory submissions related to drug safety. This is an exceptional career opportunity for an experienced professional to make a significant contribution to patient safety within a growing organization in Polokwane, Limpopo. The Polokwane, Limpopo area provides a solid base for healthcare professionals.

Key Responsibilities

• Oversee the collection, processing, and assessment of adverse event reports from all sources.
• Ensure timely and accurate reporting of adverse events to regulatory authorities in compliance with global regulations.
• Conduct signal detection activities to identify potential new safety concerns for company products.
• Prepare and maintain safety database documentation and ensure data quality and integrity.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Development) and external partners on safety-related matters.
• Contribute to the development and updating of Risk Management Plans (RMPs) and Risk-Benefit Assessments (RBAs).
• Participate in regulatory inspections and audits related to pharmacovigilance activities.
• Stay updated on global pharmacovigilance regulations and guidelines, ensuring company compliance.
• Mentor and provide guidance to junior pharmacovigilance staff.

Requirements

• Bachelor's degree in Pharmacy, Medicine, Nursing, or a related healthcare/life science field. A Master's degree is advantageous.
• Minimum of 5 years of experience in pharmacovigilance, drug safety, or a related regulatory function within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations (e.g., GVP modules, FDA regulations, SAHPRA requirements).
• Proven experience with safety databases (e.g., Argus, ArisG) and case processing.
• Strong analytical skills with the ability to interpret complex safety data and identify safety signals.
• Excellent written and verbal communication skills, including proficiency in regulatory reporting.
• High level of attention to detail and accuracy.
• Ability to work independently and as part of a collaborative team.
• Experience in developing and implementing pharmacovigilance SOPs is a plus.

Benefits

Our client offers a competitive salary, comprehensive health and retirement benefits, annual performance bonuses, and generous paid time off. The company provides excellent opportunities for professional growth, including advanced training in pharmacovigilance and related fields, conference attendance, and clear pathways for career advancement. Join a team dedicated to ensuring the safety of medicines and making a real difference in public health. The Polokwane, Limpopo location offers a solid professional environment.