Pharmacovigilance Officer

Placements24; Queenstown; Hybrid; NZD 38.000 - 63.000; Vollzeit

Benefits dieser Stelle

Hybrid work environment

Health insurance provided

Professional development opportunities

Flexible leave policy

Zusammenfassung

Placements24 is seeking a Pharmacovigilance Officer to join our client’s safety monitoring team in a hybrid role based in Queenstown (Queenstown, Eastern Cape). The role focuses on collecting, assessing, and reporting adverse events to ensure global regulatory compliance and patient safety.

You will maintain PV databases, assess causality, and contribute to PSURs/PBRERs while collaborating with Regulatory Affairs and Medical Affairs to uphold the highest drug safety standards.

Qualifikationen

• Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences or related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Strong knowledge of global pharmacovigilance regulations (ICH, GVP).
• Proficiency with pharmacovigilance databases and safety reporting systems.
• Excellent analytical and communication skills, with attention to detail.

Aufgaben

• Collect, process, and evaluate adverse event reports from healthcare professionals, patients, and literature.
• Ensure timely and accurate reporting to regulatory authorities worldwide.
• Maintain pharmacovigilance databases with high data quality.
• Assess causality of adverse events and identify potential safety signals.
• Contribute to PSURs/PBRERs and safety-related documents.
• Collaborate with Regulatory Affairs and Medical Affairs on safety matters.
• Stay updated on pharmacovigilance regulations and guidelines.
• Support audits and inspections related to pharmacovigilance activities.

Kenntnisse

Pharmacovigilance

Drug safety

Data analysis

Regulatory knowledge

Safety reporting systems

Ausbildung

Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences

Tools

PV databases

Safety reporting systems

Jobbeschreibung

About the Role

Our client, a prominent pharmaceutical company committed to patient safety, is seeking a dedicated Pharmacovigilance Officer to join their safety monitoring team. This role will operate in a hybrid capacity, supporting operations based in **Queenstown, Eastern Cape**. You will be responsible for the collection, assessment, and reporting of adverse event data to ensure compliance with global regulatory requirements. This position requires a keen eye for detail, a strong understanding of medical terminology, and a commitment to upholding the highest standards of drug safety. The successful candidate will play a crucial role in monitoring the safety profile of our client's pharmaceutical products, contributing directly to public health and patient well-being. Join a committed team focused on safety and excellence in **Queenstown**.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources (e.g., healthcare professionals, patients, literature).
• Ensure timely and accurate reporting of adverse events to regulatory authorities worldwide.
• Maintain pharmacovigilance databases and ensure data quality and integrity.
• Assess the causality of adverse events and identify potential safety signals.
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs).
• Collaborate with internal departments (e.g., Regulatory Affairs, Medical Affairs) and external stakeholders on safety matters.
• Stay updated on relevant pharmacovigilance regulations and guidelines.
• Participate in the development and review of safety-related documents and procedures.
• Support audits and inspections related to pharmacovigilance activities.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, GVP).
• Proficiency in using pharmacovigilance databases and safety reporting systems.
• Excellent analytical skills and ability to critically evaluate safety data.
• Strong understanding of medical terminology.
• Excellent written and verbal communication skills, with meticulous attention to detail.
• Ability to work independently and manage workload effectively in a hybrid setting.
• Experience or familiarity with **Queenstown, Eastern Cape** is an advantage.

Benefits

• Competitive annual salary and performance-based bonuses.
• Comprehensive health and retirement benefits.
• Generous annual leave allowance.
• Opportunities for professional development and training in pharmacovigilance.
• Flexible hybrid working arrangements.
• Contribution to ensuring the safety of pharmaceutical products.
• A collaborative and supportive work environment.