Senior Pharmacovigilance Officer

Placements24; Queenstown; Hybrid; NZD 65,000 - 98,000; Full time

Benefits offered by this job

Competitive salary and bonuses

Health insurance

Retirement benefits

Fully remote work

Professional development

Diverse product exposure

Job summary

Placements24 is seeking a Senior Pharmacovigilance Officer for a remote role in South Africa. The position focuses on monitoring, processing and reporting adverse events to ensure patient safety and regulatory compliance.

You will lead case processing, contribute to PSURs, and collaborate with Medical, Quality Assurance, and Clinical teams. Remote work offers flexibility while upholding rigorous safety standards.

Qualifications

• Bachelor's degree in Pharmacy, Medicine, Nursing, Life Sciences, or related field.
• 4–6 years in pharmacovigilance or drug safety.
• Knowledge of GVP modules and regulatory reporting.
• Experience with AE data collection and safety databases.
• Strong written and verbal communication skills.

Responsibilities

• Collect, process, and document AE reports from sources.
• Report safety information to authorities and stakeholders.
• Perform case processing including seriousness and causality.
• Contribute to PSURs and safety documents.
• Support audits and pharmacovigilance procedures.
• Collaborate with Medical, QA, and Clinical teams.
• Mentor junior staff as required.

Skills

Pharmacovigilance

GVP knowledge

AE reporting

Data analysis

Remote work

Education

Bachelor's degree in Pharmacy or related health field

Job description

About the Role Our client, a dedicated pharmaceutical company focused on patient safety, is seeking a Senior Pharmacovigilance Officer to join their team in Queenstown, Eastern Cape . This crucial role involves the meticulous monitoring, detection, assessment, and prevention of adverse effects related to medicinal products. The successful candidate will be responsible for managing safety data, ensuring compliance with regulatory reporting requirements, and contributing to risk management activities. This position offers a remote work arrangement, allowing the officer to perform their duties effectively from home. You will be a key contributor to maintaining the safety profile of our client's pharmaceutical portfolio and upholding global safety standards. Our client is committed to a culture of safety, integrity, and continuous learning in pharmacovigilance.

Key Responsibilities

• Collect, process, and document adverse event (AE) reports from various sources.
• Ensure timely and accurate reporting of safety information to regulatory authorities and internal stakeholders.
• Perform case-processing activities, including medical assessment of AEs and determination of seriousness and causality.
• Contribute to the preparation of Periodic Safety Update Reports (PSURs) and other regulatory safety documents.
• Participate in the development and implementation of pharmacovigilance procedures and policies.
• Conduct literature searches for safety-related information.
• Support risk management activities and pharmacovigilance audits.
• Train and mentor junior pharmacovigilance staff as required.
• Collaborate with internal departments (e.g., Medical, Clinical, Quality Assurance) on safety-related matters.

Requirements

• Bachelor's degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 4-6 years of experience in pharmacovigilance or drug safety.
• In-depth knowledge of pharmacovigilance principles, regulatory requirements (e.g., GVP modules, SAHPRA regulations), and safety reporting.
• Proven experience in AE data collection, processing, and reporting.
• Familiarity with safety databases and electronic reporting systems.
• Strong analytical and critical thinking skills.
• Excellent written and verbal communication abilities.
• Ability to work independently and manage responsibilities effectively in a remote setting.
• High attention to detail and commitment to accuracy.
• Experience with signal detection and risk assessment is advantageous.

Benefits

• Competitive salary and performance-related bonuses.
• Comprehensive health insurance and retirement benefits.
• Opportunities for professional development and ongoing training in pharmacovigilance.
• Fully remote work arrangement, providing flexibility and work-life balance.
• Exposure to diverse pharmaceutical products and safety profiles.
• A supportive and quality-focused work environment.