Senior Pharmacovigilance Officer

About the Role

Our client is seeking an experienced Senior Pharmacovigilance Officer to join their dedicated safety surveillance team in Klerksdorp . This role is crucial for monitoring the safety of pharmaceutical products post-marketing, ensuring patient safety, and maintaining regulatory compliance. You will be responsible for the collection, assessment, and reporting of adverse event data. This position offers a vital role within a growing pharmaceutical company in the North West province, contributing to the ongoing safety of marketed drugs.

Key Responsibilities

• Manage and process adverse event reports, ensuring timely and accurate data entry into safety databases.
• Perform aggregate data reviews and prepare periodic safety update reports (PSURs) and other regulatory safety submissions.
• Conduct signal detection activities to identify potential new safety concerns associated with medicinal products.
• Ensure compliance with global pharmacovigilance regulations and company standard operating procedures (SOPs).
• Collaborate with medical affairs, clinical operations, and regulatory affairs teams on safety-related matters.
• Provide training to internal staff and external partners on pharmacovigilance requirements.

Requirements

• Bachelor's or Master's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 5 years of experience in pharmacovigilance or drug safety.
• Strong understanding of global pharmacovigilance regulations and guidelines (e.g., GVP, FDA regulations).
• Experience with safety database systems (e.g., Argus, ArisG) is essential.
• Excellent analytical skills, attention to detail, and ability to manage complex data sets.
• Proficiency in written and verbal communication, with the ability to convey complex safety information clearly.

Benefits

• Competitive annual salary and benefits package.
• Opportunities for career advancement within drug safety and pharmacovigilance.
• Professional development and training programs focused on safety surveillance.
• Supportive team environment focused on patient safety in Klerksdorp .
• Contribution to safeguarding public health through rigorous drug safety monitoring.

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