Drug Safety Specialist

Placements24; Mossel Bay; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Generous paid time off

Professional development opportunities

Fully remote work arrangement

Job summary

Placements24 is seeking a vigilant Drug Safety Specialist to join its pharmacovigilance team. This fully remote role focuses on collecting, assessing, and reporting adverse event data to global regulators, ensuring compliance and patient safety from a home office.

You will collaborate with Medical Affairs, Regulatory Affairs, and Clinical Operations, maintaining data quality within the PV system and contributing to safety documentation and risk management plans.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field.
• Minimum of 3 years in pharmacovigilance or drug safety.
• Strong understanding of global PV regulations and reporting requirements (FDA/EMA).
• Experience with safety databases and adverse event reporting systems.
• Excellent written and verbal communication with attention to detail.

Responsibilities

• Receive, process, and assess adverse event reports from multiple sources.
• Ensure timely and accurate reporting to regulatory authorities worldwide.
• Conduct literature searches for potential safety signals.
• Collaborate with Medical Affairs, Regulatory Affairs, and other departments for case processing.
• Maintain pharmacovigilance database ensuring data quality and integrity.
• Contribute to safety documents like Investigator's Brochures and Risk Management Plans.

Skills

Pharmacovigilance

Adverse event reporting

Regulatory compliance

Data integrity

Remote work

Education

Bachelor's degree in Pharmacy/Life Sciences

Tools

Argus Safety

Safety Database

Job description

About the Role

Our client is looking for a vigilant and thorough Drug Safety Specialist to join their pharmacovigilance team. This is a fully remote position, allowing you to contribute to patient safety from the comfort of your home office. You will be responsible for the collection, assessment, and reporting of adverse event data for assigned pharmaceutical products. Your role is critical in ensuring compliance with global regulatory requirements for pharmacovigilance and in safeguarding the well-being of patients who use our client's medications. This role demands a keen eye for detail, strong analytical skills, and a commitment to ethical data handling.

Key Responsibilities

• Receive, process, and assess adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure timely and accurate reporting of adverse events to regulatory authorities worldwide, adhering to specific timelines.
• Conduct literature searches for potential safety signals and emerging safety concerns.
• Collaborate with internal departments (e.g., Medical Affairs, Regulatory Affairs, Clinical Operations) and external partners to gather necessary information for case processing.
• Maintain the pharmacovigilance database, ensuring data quality and integrity.
• Contribute to the development and updating of safety-related documents, such as Investigator's Brochures and Risk Management Plans.

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 and reporting requirements (e.g., FDA, EMA).
• Experience with safety databases and adverse event reporting systems.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage workload effectively, and meet strict deadlines in a remote environment.

Benefits

• Competitive annual salary and bonus opportunities.
• Fully remote work arrangement with flexibility.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holiday leave.
• Opportunities for continuous learning and professional development in pharmacovigilance.
• A supportive virtual culture focused on patient safety and ethical practices.