Senior Pharmacovigilance Specialist (Queenstown)

Placements24; Queenstown; Hybrid; NZD 100,000 - 140,000; Full time

Benefits offered by this job

Medical aid

Retirement fund contributions

Hybrid work model

Job summary

Placements24 is seeking a Senior Pharmacovigilance Specialist to support post-marketing safety activities in Queenstown. The role requires extensive experience in drug safety, AE processing, and regulatory reporting within a hybrid work setup.

You will contribute to PSURs, safety evaluations, and risk management, ensuring data integrity and compliant communication with health authorities. Strong analytical and collaborative skills are essential.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences or related healthcare field.
• 4–6 years of direct pharmacovigilance or drug safety experience.
• Strong knowledge of global PV regulations (ICH E2A/E2B/E2C) and SAHPRA requirements.
• Experience with adverse event processing and regulatory reporting.
• Proficiency with PV databases and pharmacovigilance software.
• Excellent written and verbal communication skills.

Responsibilities

• Collect, evaluate, and report adverse event data per regulatory requirements and SOPs.
• Medical review and assessment of individual case safety reports (ICSRs).
• Prepare PSURs and other regulatory safety documents.
• Ensure timely and accurate safety reporting to health authorities.
• Participate in risk management planning and implementation.
• Maintain safety databases and ensure data quality.

Skills

Adverse event reporting

Regulatory compliance

Data analysis

Cross-functional collaboration

Pharmacovigilance knowledge

Education

Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field

Tools

Safety databases

Pharmacovigilance software

Job description

About the Role

Our client, a pharmaceutical company dedicated to patient safety, is seeking a highly experienced and diligent Senior Pharmacovigilance Specialist to support their operations in Queenstown, Eastern Cape . This hybrid role involves the critical task of monitoring the safety of pharmaceutical products post-marketing, ensuring compliance with global safety regulations, and contributing to the robust pharmacovigilance system. The ideal candidate will possess a strong background in drug safety surveillance, adverse event reporting, and regulatory compliance. You will be responsible for collecting, assessing, and reporting adverse event data, as well as contributing to safety evaluations and risk management plans. This position requires exceptional attention to detail, analytical skills, and the ability to work effectively within a team and independently. Your role is pivotal in safeguarding public health by ensuring the safe use of our client's medicines.

Key Responsibilities

• Collect, evaluate, and report adverse event data from various sources in accordance with regulatory requirements and company SOPs.
• Perform medical review and assessment of individual case safety reports (ICSRs).
• Contribute to the preparation of periodic safety update reports (PSURs) and other regulatory safety documents.
• Ensure timely and accurate reporting of safety information to health authorities.
• Participate in risk management planning and implementation activities.
• Maintain safety databases and ensure data quality and integrity.
• Liaise with internal departments and external stakeholders on pharmacovigilance matters.
• Stay updated on global pharmacovigilance regulations and guidelines.
• Contribute to the development and revision of pharmacovigilance SOPs.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• A minimum of 4-6 years of direct experience in pharmacovigilance or drug safety.
• Thorough knowledge of global pharmacovigilance regulations (e.g., ICH E2A, E2B, E2C) and SAHPRA requirements.
• Experience with adverse event case processing and regulatory reporting.
• Proficiency in safety databases and pharmacovigilance software.
• Strong analytical skills and the ability to assess safety data critically.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a hybrid work environment.

Benefits

This role offers a competitive salary and a comprehensive benefits package, including medical aid and retirement fund contributions. The hybrid work model provides flexibility, blending remote work with essential on-site activities. Our client is committed to employee development and offers opportunities for continuous learning and professional growth. You will work in a supportive environment within a company dedicated to patient safety and ethical practices. Join a team that plays a crucial role in ensuring the well-being of patients using our client's medications in Queenstown .