Remote Pharmacovigilance Specialist

Placements24; Bloemfontein; Hybrid; ZAR 480,000 - 720,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plan

Remote work

Job summary

Placements24 is recruiting a Pharmacovigilance Specialist for a fully remote role within South Africa. You will monitor, evaluate, and report on drug safety data, supporting regulatory requirements and patient safety.

The position offers flexibility to work from home while contributing to a global safety framework. Applicants should have 3+ years in pharmacovigilance, a healthcare degree, and strong analytical and communication skills.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences or related healthcare field.
• 3+ years experience in pharmacovigilance or drug safety.
• Understanding of global pharmacovigilance regulations (FDA/EMA) and ICH guidelines.
• Experience with adverse event case processing and safety database management systems.
• Strong analytical and communication skills.
• Ability to work independently in a remote setup and meet deadlines.

Responsibilities

• Process and manage adverse event reports from healthcare professionals, patients, and literature.
• Perform medical assessment of adverse events and assign causality.
• Ensure timely submission of regulatory safety reports to authorities worldwide.
• Participate in signal detection activities and risk assessment processes.
• Contribute to preparation of aggregate safety reports (PSURs/DSURs).
• Maintain pharmacovigilance databases with data accuracy.
• Collaborate with Medical Affairs, Regulatory Affairs, and Clinical Operations on safety matters.
• Assist in development and maintenance of pharmacovigilance SOPs.
• Conduct literature reviews for potential safety signals.
• Respond to safety inquiries from authorities and stakeholders.

Skills

Adverse event processing

Pharmacovigilance

Signal detection

Regulatory compliance

Data analysis

Education

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

Tools

Safety databases

Job description

About the Role

Our client, a global leader in pharmaceutical research and development, is seeking a highly skilled and motivated Pharmacovigilance Specialist to join their dedicated team. This is a fully remote position, offering the flexibility to work from anywhere within South Africa, with a focus on supporting regulatory compliance and patient safety. The Pharmacovigilance Specialist will play a critical role in monitoring, detecting, and assessing adverse events related to our client's pharmaceutical products. You will be responsible for case processing, signal detection, and contributing to safety reporting requirements. This role is ideal for an individual with a strong understanding of drug safety principles and regulatory requirements, looking for a challenging and rewarding career in a remote setting. We are seeking a proactive individual who can work independently, manage their time effectively, and contribute to a robust pharmacovigilance system that protects public health. The successful candidate will be a key part of ensuring the safety profile of our client's medicines is rigorously maintained.

Key Responsibilities

• Process and manage adverse event reports received from various sources (healthcare professionals, patients, literature).
• Perform medical assessment of adverse event reports and assign causality.
• Ensure timely submission of regulatory safety reports to health authorities worldwide.
• Participate in signal detection activities and risk assessment processes.
• Contribute to the preparation of aggregate safety reports (e.g., PSURs, DSURs).
• Maintain the pharmacovigilance database, ensuring data accuracy and completeness.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Operations) on safety-related matters.
• Assist in the development and maintenance of pharmacovigilance Standard Operating Procedures (SOPs).
• Conduct literature reviews for potential safety signals.
• Respond to safety inquiries from regulatory authorities and internal stakeholders.
• Stay current with global pharmacovigilance regulations and guidelines.

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.
• Thorough understanding of global pharmacovigilance regulations (e.g., FDA, EMA requirements) and ICH guidelines.
• Experience with adverse event case processing and safety database management systems.
• Strong analytical skills with the ability to assess medical information and identify safety trends.
• Excellent written and verbal communication skills.
• Ability to work independently, manage time effectively, and meet strict deadlines in a remote work environment.
• Detail-oriented with strong organizational skills.
• Proficiency in common office software (Microsoft Office Suite).
• Experience with signal detection methodologies is a plus.

Benefits

Our client offers a competitive salary, comprehensive health insurance, and a retirement savings plan, all designed for remote employees. This role provides significant flexibility and the opportunity to work from anywhere in South Africa. We support professional development through online training, virtual conferences, and access to industry resources. Our client is committed to fostering a culture of work-life balance and employee well-being, ensuring a productive and engaging remote work experience. This position offers the chance to significantly contribute to global patient safety from the comfort of your home office.