Pharmacovigilance Specialist

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

Benefits offered by this job

Health insurance

Retirement contributions

Life assurance

Generous annual leave

Job summary

Placements24 in Polokwane, Limpopo, ZA, seeks a Pharmacovigilance Specialist to monitor drug safety, collect and assess AE data, and ensure regulatory compliance. You will manage safety reporting, PSURs, and safety communications while collaborating with Medical Affairs, Regulatory, and Clinical teams.

The role emphasizes accuracy, timely reporting, and staying current with ICH PV guidelines in a fast-paced environment. A healthcare degree and PV experience are essential.

Qualifications

• Strong analytical and critical thinking skills.
• Excellent attention to detail and accuracy in data handling and reporting.
• Good written and verbal communication skills.
• Proficiency in Microsoft Office Suite.
• Experience with pharmacovigilance databases and safety reporting systems.

Responsibilities

• Collect, assess, and document adverse event reports from various sources.
• Ensure accurate and timely reporting of adverse events to regulatory authorities and internal stakeholders.
• Maintain and update the pharmacovigilance database with all relevant safety information.
• Participate in signal detection and risk assessment activities.
• Contribute to the preparation of PSURs and other safety documents.
• Collaborate with Medical Affairs, Clinical Operations and Regulatory Affairs on safety matters.
• Ensure compliance with pharmacovigilance regulations and SOPs.
• Stay updated on global PV guidelines and best practices.
• Assist in developing PV training programs.
• Respond to safety inquiries from regulatory authorities and business partners.

Skills

Analytical thinking

Attention to detail

Communication skills

Office software

PV databases knowledge

Education

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

Job description

About the Role

Our client, a globally recognized pharmaceutical innovator, is seeking a diligent Pharmacovigilance Specialist to join their dedicated team in Polokwane, Limpopo, ZA . This vital role involves the continuous monitoring of drug safety, ensuring that potential risks associated with our pharmaceutical products are identified, assessed, and managed effectively. You will be responsible for the collection, processing, and reporting of adverse event data, ensuring compliance with all relevant national and international pharmacovigilance regulations. This is a critical position for ensuring patient safety and maintaining the integrity of our product portfolio. The Polokwane location provides a strategic base for contributing to global drug safety initiatives.

Key Responsibilities

• Collect, assess, and document adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure accurate and timely reporting of adverse events to regulatory authorities and internal stakeholders according to established timelines.
• Maintain and update the pharmacovigilance database with all relevant safety information.
• Participate in signal detection and risk assessment activities to identify potential safety concerns.
• Contribute to the preparation of periodic safety update reports (PSURs) and other safety documents.
• Collaborate with internal departments (e.g., Medical Affairs, Clinical Operations, Regulatory Affairs) on safety-related matters.
• Ensure compliance with pharmacovigilance regulations and company Standard Operating Procedures (SOPs).
• Stay updated on global pharmacovigilance guidelines and best practices.
• Assist in the development and implementation of pharmacovigilance training programs.
• Manage and respond to safety inquiries from regulatory authorities and business partners.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field.
• Minimum of 3-5 years of experience in pharmacovigilance or drug safety.
• Strong understanding of global pharmacovigilance regulations (e.g., ICH E2A, E2B, E2C) and reporting requirements.
• Experience with pharmacovigilance databases and safety reporting systems.
• Excellent attention to detail and accuracy in data handling and reporting.
• Strong analytical and critical thinking skills.
• Proficiency in medical terminology and understanding of clinical trial processes.
• Good written and verbal communication skills.
• Ability to work effectively in a team and manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office Suite.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including health insurance, retirement contributions, and life assurance.
• We are committed to fostering employee growth through ongoing training, professional development opportunities, and exposure to diverse safety challenges.
• This role is based in our modern facility in Polokwane , offering a stable and supportive work environment.
• Generous annual leave and opportunities for career advancement within the pharmacovigilance department are key benefits.

Join a company that prioritizes patient safety and ethical conduct, making a real difference in global healthcare.