Senior Pharmacovigilance Specialist - Global Drug Safety

Placements24; Pietermaritzburg; Sur place; ZAR 550 000 - 850 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement contributions

Paid time off

Professional development opportunities

Conference attendances

Résumé du poste

Placements24 seeks a Senior Pharmacovigilance Specialist in Pietermaritzburg, SA, to lead safety data collection, assessment and regulatory reporting. You will manage case processing, safety databases, and post-marketing surveillance while advancing risk management activities.

You will collaborate with Clinical Operations, Regulatory Affairs and Medical Affairs to ensure compliance with FDA/EMA/SAHPRA guidelines and contribute to safety documentation and SOPs.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 4 years of experience in pharmacovigilance/drug safety.
• Thorough knowledge of global pharmacovigilance regulations (FDA, EMA, SAHPRA).
• Experience with safety database systems (Argus, ARISg) and case processing.
• Understanding of clinical trial safety reporting and post-marketing surveillance.
• Excellent attention to detail, organizational skills, and ability to manage multiple tasks.
• Strong written and verbal communication skills.

Responsabilités

• Process, assess, and report adverse event cases in compliance with global regulatory timelines and standards.
• Ensure accurate and timely entry of safety data into the pharmacovigilance database.
• Conduct safety assessments of clinical trial data and post-marketing reports.
• Prepare aggregate safety reports (PBRERs/PSURs) for regulatory submission.
• Collaborate with Clinical Operations, Regulatory Affairs, Medical Affairs and external partners for safety information.
• Develop and maintain pharmacovigilance SOPs.
• Contribute to risk management activities and Risk Management Plans (RMPs).
• Stay updated on evolving pharmacovigilance regulations and guidelines.

Connaissances

Attention to detail

Organizational skills

Multitasking

Written communication

Verbal communication

Teamwork

Formation

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

Outils

Argus

ARISg

Description du poste

Placements24 seeks a Senior Pharmacovigilance Specialist in Pietermaritzburg, SA, to lead safety data collection, assessment and regulatory reporting. You will manage case processing, safety databases, and post-marketing surveillance while advancing risk management activities.

You will collaborate with Clinical Operations, Regulatory Affairs and Medical Affairs to ensure compliance with FDA/EMA/SAHPRA guidelines and contribute to safety documentation and SOPs.