Senior Pharmacovigilance Specialist

Placements24; LegKraal Gate; On-site; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Professional development

Job summary

Placements24 is seeking an experienced Senior Pharmacovigilance Specialist to join our safety surveillance team in Mahikeng. You will monitor the post-marketing safety profile of pharmaceutical products, manage adverse event reporting, and ensure compliance with global regulatory requirements.

The ideal candidate will have at least five years in pharmacovigilance, a life sciences degree, and strong data analysis, communication, and mentoring skills.

Qualifications

• Bachelor's degree in a life science field; advanced degree preferred.
• Minimum 5 years of pharmacovigilance or drug safety experience.
• Strong knowledge of global PV regulations (FDA, EMA, CIOMS).
• Experience with safety databases and adverse event reporting systems.

Responsibilities

• Manage collection, assessment, and regulatory reporting of adverse event data.
• Perform aggregate data reviews and signal detection.
• Contribute to PSURs and Risk Management Plans (RMPs).
• Ensure compliance with global pharmacovigilance regulations and SOPs.
• Liaise with Clinical, Regulatory, Medical Affairs and external stakeholders on safety matters.
• Train and mentor junior members of the pharmacovigilance team.

Skills

Analytical thinking

Regulatory knowledge

Communication skills

Problem solving

Attention to detail

Education

Bachelor's degree in Pharmacy/Medicine/Nursing or related life science

Tools

Safety databases

Adverse event reporting systems

Job description

About the Role

Our client is seeking an experienced and proactive Senior Pharmacovigilance Specialist to join their safety surveillance team in Mahikeng . This role is critical for monitoring the safety profile of pharmaceutical products post-marketing, ensuring compliance with global regulatory requirements, and protecting patient safety. You will be responsible for managing adverse event reporting, conducting signal detection activities, and contributing to risk management plans. The ideal candidate possesses a strong understanding of pharmacovigilance principles, regulatory guidelines, and data analysis, with a commitment to maintaining the highest standards of patient safety within the pharmaceutical industry .

Key Responsibilities

• Manage the collection, assessment, and regulatory reporting of adverse event data from various sources.
• Perform aggregate data review and signal detection activities to identify potential safety issues.
• Contribute to the preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Ensure compliance with global pharmacovigilance regulations and company SOPs.
• Liaise with internal departments (Clinical, Regulatory, Medical Affairs) and external stakeholders on safety matters.
• Train and mentor junior members of the pharmacovigilance team.

Requirements

• Bachelor's degree in Pharmacy, Medicine, Nursing, or a related life science field; advanced degree preferred.
• Minimum of 5 years of experience in Pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry.
• Thorough understanding of global pharmacovigilance regulations (e.g., FDA, EMA, CIOMS).
• Experience with safety databases and adverse event reporting systems.
• Excellent analytical, critical thinking, and problem-solving skills.
• Strong written and verbal communication abilities.

Benefits

• Competitive annual salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer contribution.
• Opportunities for professional development and continued education.
• A challenging and rewarding role focused on patient safety.