About the Role
Our client, a respected name in the pharmaceutical industry, is seeking a dedicated Senior Pharmacovigilance Scientist to join their safety surveillance team. This role is based in Pretoria, Gauteng , and will be critical in ensuring the safety of our client's medicinal products. You will be responsible for monitoring, evaluating, and reporting adverse events, contributing to risk management strategies, and ensuring compliance with global regulatory requirements. This is an excellent opportunity for an experienced pharmacovigilance professional to make a significant contribution to patient safety and work within a company that values scientific integrity and rigorous safety practices.
Key Responsibilities
- Perform safety data analysis and signal detection for assigned products.
- Author and review periodic safety update reports (PSURs), development safety update reports (DSURs), and other regulatory safety documents.
- Manage and process adverse event reports, ensuring timely and accurate data entry and case processing.
- Collaborate with clinical development, regulatory affairs, and other departments to assess and manage product risks.
- Participate in safety monitoring committees and contribute to risk management plan development.
- Ensure compliance with global pharmacovigilance regulations and company procedures.
- Respond to regulatory authority inquiries related to product safety.
- Contribute to the development and improvement of pharmacovigilance processes and systems.
Requirements
- University degree in a life science, nursing, pharmacy, or medical field.
- Advanced degree (M.S., Ph.D., Pharm.D.) preferred.
- Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
- In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, CIOMS).
- Experience with safety databases (e.g., Argus, ArisG) and case processing.
- Strong analytical and critical thinking skills, with the ability to evaluate complex safety data.
- Excellent written and verbal communication skills, including report writing.
- Ability to work independently and as part of a team.
- Meticulous attention to detail and commitment to accuracy.
Benefits
- Our client offers a competitive salary and a comprehensive benefits package, including medical, dental, and vision coverage, as well as a retirement savings plan.
- Opportunities for professional development and career advancement within pharmacovigilance are readily available.
- The role is located in Pretoria, Gauteng , offering a chance to work with a dedicated safety team.