Remote Pharmacovigilance Specialist

Placements24; Randburg; Hybrid; ZAR 450,000 - 750,000; Full time

Benefits offered by this job

Fully remote work

Performance-based bonus

Health, dental and vision insurance

Professional development opportunities

Job summary

Placements24 is seeking a vigilant Remote Pharmacovigilance Specialist to join its safety surveillance team. You will monitor post-marketing drug safety, collect, assess and report adverse events, and ensure regulatory compliance.

As a fully remote role, you will collaborate with global regulatory bodies and internal teams to maintain high drug safety standards, develop PV SOPs, and contribute to safety signaling and PSUR activities.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences or related healthcare field.
• Minimum of 3 years' experience in pharmacovigilance or drug safety in pharma.
• Thorough knowledge of global PV regulations (ICH E2A/E2B/E2F).

Responsibilities

• Collect, assess and report ICSRs from multiple sources.
• Ensure timely submission of safety reports to regulators including SAHPRA.
• Perform literature searches for safety signals and contribute to signal detection.
• Prepare PSURs and other aggregate safety reports as required.
• Collaborate with Clinical Operations, Regulatory Affairs and Medical Information.
• Help develop PV SOPs and training materials.

Skills

Analytical skills

Attention to detail

Independent worker

English communication

Education

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

Tools

PV databases

Safety reporting systems

Job description

About the Role

Our client is seeking a vigilant and experienced Remote Pharmacovigilance Specialist to join their dedicated safety surveillance team. In this fully remote role, you will play a crucial part in monitoring the safety of pharmaceutical products post-marketing, ensuring patient safety by collecting, assessing, and reporting adverse events. You will collaborate with global regulatory bodies and internal teams to maintain the highest standards of drug safety. This position is ideal for a detail-oriented professional with a strong understanding of pharmacovigilance principles and a commitment to patient well-being, working from any approved location.

Key Responsibilities

• Collect, process, and assess individual case safety reports (ICSRs) from various sources (e.g., healthcare professionals, patients, literature).
• Ensure timely and accurate submission of safety reports to regulatory authorities, including SAHPRA, in compliance with applicable regulations.
• Conduct literature searches for potential safety signals and contribute to signal detection activities.
• Prepare aggregate safety reports (e.g., Periodic Safety Update Reports - PSURs) as required.
• Collaborate with internal departments (e.g., Clinical Operations, Regulatory Affairs, Medical Information) to ensure comprehensive safety data management.
• Contribute to the development and maintenance of pharmacovigilance Standard Operating Procedures (SOPs) and training materials.

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, preferably within the pharmaceutical industry.
• Thorough knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH E2A, E2B, E2F).
• Experience with pharmacovigilance databases and safety reporting systems.
• Excellent analytical skills, strong attention to detail, and the ability to work independently.
• Proficiency in English communication, both written and verbal, with the ability to clearly articulate safety information in a remote work environment.

Benefits

• Competitive salary and performance-related bonuses.
• Fully remote work flexibility, allowing for a better work-life balance.
• Comprehensive health, dental, and vision insurance plans.
• Opportunities for professional development and specialized training in pharmacovigilance.
• A vital role in safeguarding public health by ensuring drug safety.