Senior Pharmacovigilance Specialist

Placements24; Pietermaritzburg; On-site; ZAR 550,000 - 850,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Paid time off

Professional development opportunities

Conference attendances

Job summary

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.

Responsibilities

• 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.

Skills

Attention to detail

Organizational skills

Multitasking

Written communication

Verbal communication

Teamwork

Education

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

Tools

Argus

ARISg

Job description

About the Role

Our client, a forward-thinking pharmaceutical company, is seeking a dedicated and experienced Senior Pharmacovigilance Specialist to join their safety surveillance team in Pietermaritzburg, KwaZulu-Natal. This critical role ensures the safety of patients by meticulously collecting, evaluating, and reporting adverse event data for the company's pharmaceutical products. You will be instrumental in maintaining compliance with global regulatory requirements for drug safety, contributing to risk management activities, and ensuring the integrity of safety databases. The ideal candidate will possess a deep understanding of pharmacovigilance principles, regulatory reporting requirements, and case processing. Join us in Pietermaritzburg to make a significant contribution to patient safety and product stewardship.

Key Responsibilities

• Process, assess, and report adverse event cases in compliance with global regulatory timelines and standards.
• Ensure the accurate and timely entry of safety data into the pharmacovigilance database.
• Conduct initial and ongoing safety assessments of clinical trial data and post-marketing spontaneous reports.
• Prepare aggregate safety reports (e.g., PBRERs/PSURs) and other safety-related documents for regulatory submission.
• Collaborate with internal departments (e.g., Clinical Operations, Regulatory Affairs, Medical Affairs) and external partners to gather necessary safety information.
• Participate in the development and maintenance of pharmacovigilance Standard Operating Procedures (SOPs).
• Contribute to risk management activities and the development of Risk Management Plans (RMPs).
• Stay abreast of evolving global pharmacovigilance regulations and guidelines.

Requirements

• 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 (e.g., FDA, EMA, SAHPRA) and reporting requirements.
• Experience with safety database systems (e.g., 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.
• Ability to work independently and collaboratively within a team.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including health insurance, retirement contributions, and paid time off.
• We invest in our employees' professional development through ongoing training, workshops, and opportunities to attend industry conferences.
• This position is based in Pietermaritzburg, KwaZulu-Natal , providing an excellent opportunity to advance your career in drug safety within a supportive and growing organization.
• Join a team committed to ensuring the safety and efficacy of pharmaceutical products for patients worldwide.