Pharmacovigilance Officer - Drug Safety

Placements24; Benoni; On-site; ZAR 550,000 - 850,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Paid time off

Professional development opportunities

Supportive team environment

Job summary

Placements24 in Gauteng's Benoni is seeking a Pharmacovigilance Officer to join its drug safety team. Based in Benoni, the role focuses on monitoring product safety and ensuring global regulatory compliance for adverse event reporting.

You will collect, assess, and report AEs, write case narratives, ensure timely submissions to regulators, and develop PV procedures. Collaboration with clinical operations, regulatory affairs, and medical information is essential in this dynamic pharmaceutical

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related field.
• Minimum of 3 years in pharmacovigilance or drug safety in pharma.
• Solid understanding of PV principles and regulatory reporting (GVP).
• Experience with safety databases (Argus, ARISg) desirable.
• Strong analytical, detail-oriented and multitasking abilities.
• Excellent written and verbal communication for cross-functional teams.

Responsibilities

• Collect, assess, and process adverse event reports from professionals, patients, and literature.
• Write case narratives and determine seriousness of reported AEs.
• Ensure timely and accurate reporting of safety information to regulators and internal stakeholders.
• Develop and maintain pharmacovigilance procedures and training materials.
• Collaborate with clinical operations, regulatory affairs, and medical information on safety matters.
• Contribute to signal detection and risk management to mitigate safety issues.

Skills

Analytical skills

Attention to detail

Multitasking

Written and verbal communication

Education

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

Tools

Argus

ARISg

Job description

About the Role

Our client is seeking a diligent Pharmacovigilance Officer to join their dedicated drug safety team based in Benoni . This role is crucial for monitoring the safety of pharmaceutical products and ensuring compliance with global regulatory requirements for adverse event reporting. You will play a key part in safeguarding patient well-being by meticulously collecting, assessing, and reporting safety information. This position offers a rewarding opportunity to contribute to patient safety within a growing pharmaceutical company located in Gauteng .

Key Responsibilities

• Collect, assess, and process adverse event (AE) reports from various sources, including healthcare professionals, patients, and literature.
• Conduct case narrative writing and determine seriousness criteria for reported AEs.
• Ensure timely and accurate reporting of safety information to regulatory authorities and internal stakeholders.
• Participate in the development and maintenance of pharmacovigilance procedures and training materials.
• Collaborate with clinical operations, regulatory affairs, and medical information teams on safety-related matters.
• Contribute to signal detection and risk management activities to proactively identify and mitigate potential safety issues of pharmaceutical products.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety, preferably within the pharmaceutical industry.
• Solid understanding of pharmacovigilance principles and regulatory reporting requirements (e.g., GVP modules).
• Experience with safety databases (e.g., Argus, ARISg) is highly desirable.
• Strong analytical skills, attention to detail, and ability to manage multiple tasks effectively.
• Excellent written and verbal communication skills for clear reporting and interaction with cross-functional teams.

Benefits

• Competitive annual salary and potential for annual bonus.
• Comprehensive health, dental, and vision insurance coverage.
• Paid time off, including vacation and sick leave.
• Opportunities for professional development and further training in drug safety.
• A supportive team environment focused on maintaining the highest standards of patient safety.