Senior Pharmacovigilance Lead: Patient Safety & Compliance

Placements24; Klerksdorp; On-site; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Professional development opportunities

Job summary

Placements24 in Klerksdorp is seeking a Senior Pharmacovigilance Officer to join our safety surveillance team. The role focuses on post-marketing safety, ensuring patient safety and regulatory compliance in all activities.

You will manage adverse event processing, PSURs/PBRERs submissions, signal detection, risk management, and cross-functional coordination with Medical Affairs and Regulatory. A strong pharmacovigilance background is essential.

Qualifications

• Bachelor's degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety.
• Knowledge of pharmacovigilance principles, adverse event reporting, and regulatory requirements (e.g., GVP, FDA).
• Experience with safety databases and case processing (Argus, ARISg).
• Familiarity with signal detection methodologies and risk management strategies.
• Strong analytical and critical thinking skills.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple priorities.
• Attention to detail and patient safety.
• Proficiency in relevant software applications.

Responsibilities

• Manage and process adverse event reports in accordance with regulatory requirements and SOPs.
• Perform initial assessment of adverse event reports for completeness, accuracy, and seriousness.
• Conduct literature searches for potential safety signals and new information.
• Contribute to development and implementation of risk management plans (RMPs).
• Prepare and submit periodic safety update reports (PSURs/PBRERs) to health authorities.
• Participate in signal detection activities and contribute to safety review meetings.
• Ensure compliance with global pharmacovigilance regulations and guidelines.
• Maintain accurate and up-to-date pharmacovigilance databases.
• Train and mentor junior pharmacovigilance staff.
• Liaise with internal departments and external stakeholders on safety matters.

Skills

Analytical thinking

Critical thinking

Written communication

Verbal communication

Independent worker

Multitasking

Attention to detail

Education

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

Tools

Argus

ARISg

Job description

Placements24 in Klerksdorp is seeking a Senior Pharmacovigilance Officer to join our safety surveillance team. The role focuses on post-marketing safety, ensuring patient safety and regulatory compliance in all activities.

You will manage adverse event processing, PSURs/PBRERs submissions, signal detection, risk management, and cross-functional coordination with Medical Affairs and Regulatory. A strong pharmacovigilance background is essential.