Pharmaceutical Pharmacovigilance Specialist

Placements24; Queenstown; Hybrid; NZD 64,000 - 97,000; Full time

Benefits offered by this job

Medical aid

Retirement provisions

Professional development

Hybrid role

Performance incentives

Job summary

Placements24 is seeking a Pharmacovigilance Specialist to join the safety monitoring team in a hybrid Queenstown-based role. You will collect and evaluate adverse event reports, ensure regulatory submissions, and contribute to safety signal detection.

The role requires a strong background in pharmacovigilance, AER reporting, and medical terminology, with ability to work across clinical operations, regulatory, and medical affairs. Excellent attention to detail and communication are essential.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field is required.
• Solid understanding of pharmacovigilance principles and regulatory reporting requirements.
• Experience with adverse event reporting and data analysis is essential.

Responsibilities

• Collect, process, and evaluate adverse event reports from various sources.
• Ensure timely reporting of safety data to regulatory authorities.
• Conduct case narrative writing and medical reviews of adverse events.
• Identify potential safety signals and contribute to signal detection activities.
• Maintain pharmacovigilance databases with accurate safety information.
• Collaborate with clinical operations, regulatory affairs and medical affairs on safety matters.
• Stay up-to-date with global pharmacovigilance regulations and guidelines.
• Provide training on pharmacovigilance requirements to internal staff as needed.

Skills

Pharmacovigilance

AER reporting

Regulatory knowledge

Medical terminology

Data analysis

Communication

Education

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

Tools

Pharmacovigilance databases

Safety reporting software

Job description

About the Role

Our client, a prominent pharmaceutical organization, is seeking a dedicated Pharmacovigilance Specialist to join their safety monitoring team. This hybrid role, located in Queenstown, Eastern Cape , is crucial for ensuring the safe use of pharmaceutical products by monitoring, detecting, and preventing adverse events. The Specialist will play a key role in collecting, evaluating, and reporting safety data to regulatory authorities. This is an essential function within the pharmaceutical industry, safeguarding public health and maintaining regulatory compliance. We are seeking a meticulous and scientifically grounded individual with a strong understanding of drug safety principles and regulatory reporting requirements. Your contributions will directly impact patient safety and the responsible lifecycle management of our client's medicines.

Key Responsibilities

• Collect, process, and evaluate adverse event reports from various sources (e.g., healthcare professionals, patients, clinical trials).
• Ensure accurate and timely reporting of safety data to regulatory authorities (e.g., SAHPRA) and internal stakeholders.
• Conduct case narrative writing and perform medical reviews of adverse event reports.
• Identify potential safety signals and contribute to signal detection activities.
• Maintain and update the pharmacovigilance database with accurate safety information.
• Participate in the development and review of safety-related documents, such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Collaborate with clinical operations, regulatory affairs, and medical affairs teams on safety-related matters.
• Stay up-to-date with global pharmacovigilance regulations and guidelines.
• Contribute to the development and improvement of pharmacovigilance processes and procedures.
• Provide training on pharmacovigilance requirements to internal staff as needed.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety.
• Solid understanding of pharmacovigilance principles, adverse event reporting, and regulatory requirements.
• Familiarity with pharmacovigilance databases and safety reporting software.
• Excellent attention to detail, accuracy, and organizational skills.
• Strong written and verbal communication skills.
• Ability to work effectively both independently and as part of a hybrid team.
• Proficiency in medical terminology and data analysis.
• Familiarity with the healthcare landscape in Queenstown, Eastern Cape is a plus.
• Commitment to maintaining confidentiality and data integrity.

Benefits

Our client offers a competitive salary, comprehensive benefits package including medical aid and retirement provisions, and performance-based incentives. This hybrid role provides flexibility, allowing for a balance between remote work and in-office collaboration. Employees benefit from continuous professional development opportunities and exposure to diverse therapeutic areas. Join a dedicated team focused on ensuring the safety and efficacy of pharmaceutical products. Our client fosters a culture of integrity and responsibility, offering a stable and rewarding career path. Enjoy a supportive work environment that values your contribution to public health and safety in the Eastern Cape .