Senior Pharmacovigilance Specialist

Placements24; Bloemfontein; Hybrid; ZAR 850,000 - 1,200,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

Retirement savings plan

Professional development opportunities

Job summary

Placements24 seeks a Senior Pharmacovigilance Specialist for our Bloemfontein safety surveillance team. You will monitor, assess, and report adverse events, maintain the safety database, and contribute to regulatory safety documents to ensure patient safety.

The role requires 4–6 years PV experience, strong knowledge of ICH guidelines, and proficiency with PV databases. A robust attention to detail and excellent communication are essential for success in a collaborative environment.

Qualifications

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences or related field.
• 4–6 years direct pharmacovigilance or drug safety experience.
• Strong understanding of ICH E2A/E2B/E2C guidelines.
• Proficiency with pharmacovigilance databases and safety reporting systems.
• Excellent analytical and written/verbal communication skills.
• Ability to manage multiple tasks to tight deadlines.

Responsibilities

• Collect, process, and assess adverse event reports from various sources.
• Ensure accurate and timely entry of safety data into PV databases.
• Write case narratives with quality and consistency.
• Identify and report adverse events within required timeframes to regulatory authorities.
• Contribute to PSURs and other regulatory safety documents.
• Support audits and inspections related to pharmacovigilance.

Skills

Pharmacovigilance

Analytical skills

Attention to detail

Communication skills

Multitasking

Team player

Medical terminology

Risk management

Education

Bachelor's degree in Pharmacy, Nursing, Life Sciences

Master's degree (advantage)

Tools

PV databases

Safety reporting systems

Job description

About the Role

Our client, a rapidly expanding pharmaceutical company, is seeking a highly diligent and experienced Senior Pharmacovigilance Specialist to join their safety surveillance team in Bloemfontein . This critical role involves the meticulous monitoring, assessment, and reporting of adverse events associated with medicinal products, ensuring patient safety and regulatory compliance. You will play a key part in maintaining the company's safety database, preparing regulatory safety reports, and contributing to risk management plans. This is an excellent opportunity for a detail-oriented professional to make a significant contribution to drug safety. The position requires a strong understanding of pharmacovigilance principles and regulatory requirements. Located in Bloemfontein, Free State , this role offers a chance to work within a supportive and professional environment.

Key Responsibilities

• Collect, process, and assess adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure accurate and timely entry of safety data into the pharmacovigilance database.
• Perform case narrative writing and ensure the quality and consistency of case reports.
• Identify and report adverse events to regulatory authorities within required timeframes.
• Contribute to the preparation of periodic safety update reports (PSURs) and other regulatory safety documents.
• Participate in signal detection activities and contribute to safety assessments.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Operations) and external stakeholders on safety matters.
• Ensure compliance with global pharmacovigilance regulations and company SOPs.
• Assist in the development and maintenance of pharmacovigilance procedures and training materials.
• Support audits and inspections related to pharmacovigilance activities.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• A Master's degree is a plus.
• A minimum of 4-6 years of direct experience in pharmacovigilance or drug safety.
• Thorough understanding of global pharmacovigilance regulations and guidelines (e.g., ICH E2A, E2B, E2C).
• Proficiency in using pharmacovigilance databases and safety reporting systems.
• Excellent analytical skills with meticulous attention to detail.
• Strong written and verbal communication skills, including the ability to write clear and concise case narratives.
• Ability to manage multiple tasks and prioritize effectively in a deadline-driven environment.
• Proficiency in medical terminology and case processing.
• Team player with strong interpersonal skills and the ability to work collaboratively.
• Experience with signal detection and risk management planning is advantageous.

Benefits

• Our client offers a competitive salary and bonus structure, along with comprehensive medical, dental, and vision insurance.
• A retirement savings plan and life insurance are also provided.
• Opportunities for professional growth include access to pharmacovigilance training, conferences, and continuing education programs. The company culture emphasizes collaboration, integrity, and a commitment to patient safety. Enjoy a supportive work environment with a focus on work-life balance. This role offers the opportunity to significantly impact patient safety within a growing pharmaceutical organization in Bloemfontein .