Senior Pharmacovigilance Specialist (Remote)

Placements24; Bloemfontein; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Remote work

Health insurance

Paid time off

Professional development

Job summary

Placements24 client, a forward-looking pharmaceutical company, is seeking a Senior Pharmacovigilance Specialist to join a fully remote team. You will monitor drug safety, manage adverse event reporting globally, and ensure ongoing compliance with regulatory requirements to protect patient safety.

You will work independently, perform case processing with MedDRA coding, contribute to safety databases, and collaborate with cross-functional teams.

Qualifications

• 4+ years of experience in pharmacovigilance and drug safety principles.
• Proficiency in adverse event case processing and MedDRA coding.
• Familiarity with global PV regulatory requirements (FDA, EMA, CIOMS).
• Experience with safety databases (e.g., Argus, ArisG) is highly desirable.

Responsibilities

• Collect, assess and report adverse events per global requirements.
• Perform case processing, coding (MedDRA), and narrative writing.
• Ensure timely submission of ICSRs to regulators and stakeholders.
• Conduct literature reviews to identify potential safety signals.

Skills

Analytical

Organizational skills

Problem solving

Communication

Remote autonomy

Education

Bachelor's degree in Pharmacy

Life Sciences

Tools

Argus

ArisG

Job description

About the Role

Our client, a progressive pharmaceutical company committed to patient safety, is seeking a Senior Pharmacovigilance Specialist to join their fully remote team. This role is critical in ensuring the continuous monitoring of drug safety profiles and managing adverse event reporting globally. You will play a key part in maintaining compliance with regulatory requirements and contributing to the safety assessment of medicinal products. This is an ideal opportunity for an experienced pharmacovigilance professional who thrives in a remote work environment and seeks to make a significant impact on patient well-being from anywhere. You will work independently, leveraging your expertise to uphold the highest safety standards.

Key Responsibilities

• Collect, assess, and report adverse event data in accordance with global regulatory requirements and company procedures.
• Perform case processing, including data entry, coding (MedDRA), and narrative writing for adverse event reports.
• Ensure timely submission of individual case safety reports (ICSRs) to regulatory authorities and other stakeholders.
• Conduct literature reviews to identify potential safety signals and contribute to signal detection activities.
• Support the development and maintenance of safety databases and pharmacovigilance systems.
• Collaborate with internal departments (e.g., Clinical, Regulatory, Medical Affairs) and external partners on safety-related matters.
• Assist in the preparation of aggregate safety reports, such as Periodic Benefit-Risk Evaluations (PBRERs) and Development Safety Update Reports (DSURs).
• Contribute to the development and implementation of pharmacovigilance policies and procedures.
• Participate in audits and inspections related to pharmacovigilance activities.
• Stay current with global pharmacovigilance regulations and industry best practices.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 4 years of experience in pharmacovigilance, with a strong understanding of drug safety principles and processes.
• Proficiency in adverse event case processing and reporting, including experience with MedDRA coding.
• Familiarity with global regulatory requirements for pharmacovigilance (e.g., FDA, EMA, CIOMS).
• Experience with safety databases (e.g., Argus, ArisG) is highly desirable.
• Excellent analytical, organizational, and problem-solving skills.
• Strong written and verbal communication skills, with meticulous attention to detail.
• Ability to work autonomously and manage workload effectively in a remote setting.
• Proactive approach to identifying and resolving safety issues.
• Demonstrated ability to collaborate effectively with remote colleagues and stakeholders.

Benefits

Our client offers a competitive salary, comprehensive remote work benefits package including health, dental, and vision insurance, a generous retirement savings plan, and paid time off. This is a fully remote position, offering unparalleled flexibility. You will have access to ongoing professional development, including training and opportunities to attend virtual industry events. Join a forward-thinking company that prioritizes patient safety and offers a supportive, results-oriented remote work culture.