Senior Pharmaceutical Pharmacovigilance Specialist

Placements24; Upington; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Competitive salary and benefits

Professional development opportunities

Exposure to diverse pharmaceutical产品

Stable Upington work environment

Generous leave

Job summary

Placements24 is actively seeking a Senior Pharmaceutical Pharmacovigilance Specialist for our client in Upington, Northern Cape. You will oversee adverse event reporting, perform signal detection, and prepare aggregate safety reports to support global regulatory compliance.

Requirements include a degree in Medicine, Pharmacy, Life Sciences, or a related field, and a minimum of 5 years in pharmacovigilance. The role involves cross‑functional collaboration with Medical Affairs and Regulatory

Qualifications

• Minimum 5 years of pharmacovigilance or drug safety experience.
• Thorough knowledge of global PV regulations and reporting requirements.
• Experience with adverse event case processing and regulatory reporting systems.
• Strong communication and attention to detail.

Responsibilities

• Manage collection, processing, and reporting of AE and product complaint data.
• Conduct signal detection to identify safety issues.
• Prepare PSURs/DSURs for regulatory submission.
• Ensure compliance with GVP modules and CIOMS guidelines.
• Collaborate with Medical Affairs, Regulatory Affairs, and Clinical Development on safety matters.
• Develop and maintain PV SOPs and participate in risk management plans.
• Perform literature reviews for safety information and trends.
• Train personnel on PV requirements and procedures.
• Act as subject matter expert on drug safety and PV issues.

Skills

PV expertise

Regulatory knowledge

Analytical thinking

Education

Healthcare degree (Medicine/Pharmacy/Life Sciences)

Tools

PV databases

Regulatory reporting tools

Microsoft Office

Job description

About the Role

Our client, a leading pharmaceutical company with operations in Upington, Northern Cape , is actively seeking a dedicated Senior Pharmaceutical Pharmacovigilance Specialist. This critical role ensures the safety and ongoing monitoring of pharmaceutical products once they are on the market. The Specialist will be responsible for managing adverse event reporting, conducting signal detection and assessment, and ensuring compliance with global pharmacovigilance regulations. The ideal candidate will possess a strong understanding of drug safety principles and regulatory requirements within the pharmaceutical industry. Join our client's committed team in Upington and play a vital role in patient safety.

Key Responsibilities

• Manage the collection, processing, and reporting of adverse event (AE) and product complaint data.
• Conduct signal detection activities to identify potential safety issues associated with pharmaceutical products.
• Prepare aggregate safety reports (e.g., PSURs, DSURs) for submission to regulatory authorities.
• Ensure compliance with all applicable pharmacovigilance regulations and guidelines (e.g., GVP modules, CIOMS).
• Liaise with internal departments (Medical Affairs, Regulatory Affairs, Clinical Development) and external stakeholders (healthcare professionals, regulatory agencies) on safety matters.
• Contribute to the development and maintenance of pharmacovigilance Standard Operating Procedures (SOPs).
• Participate in risk management plan development and implementation.
• Perform literature reviews for safety information and emerging trends.
• Train relevant personnel on pharmacovigilance requirements and procedures.
• Act as a subject matter expert on drug safety and pharmacovigilance issues.

Requirements

• Degree in Medicine, Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• A minimum of 5 years of experience in pharmacovigilance or drug safety.
• Thorough knowledge of global pharmacovigilance regulations and reporting requirements.
• Experience with adverse event case processing and regulatory reporting systems.
• Familiarity with signal detection methodologies and aggregate safety reporting.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with high attention to detail.
• Ability to work independently and manage workload effectively in a demanding environment.
• Proficiency in pharmacovigilance database systems and common office software.
• Prior experience in the pharmaceutical industry within the Northern Cape or similar context is beneficial.

Benefits

• Competitive salary and a comprehensive benefits package.
• Opportunities for continuous professional development and training in drug safety.
• Exposure to a wide range of pharmaceutical products and safety profiles.
• A stable and supportive work environment in Upington .
• Generous paid time off and company holidays.
• Potential for career growth within a growing organization.