Pharmacovigilance Specialist

Placements24; Durban; On-site; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Competitive salary

Remote work flexibility

Health and wellness benefits

Professional growth and training

Safety culture and improvement

Job summary

Placements24 in Durban seeks a Pharmacovigilance Specialist to monitor, assess and report adverse events, ensuring compliance with global safety regulations and supporting risk management activities.

The role involves PV database work, collaboration with Regulatory, Medical and Clinical teams, and contributing to safety literature. Flexible remote work options and health benefits are included.

Qualifications

• A degree in Pharmacy, Nursing, Life Sciences or a related field is required.
• Minimum of 3 years' experience in pharmacovigilance or drug safety within the pharmaceutical sector.
• Strong understanding of global drug safety regulations and reporting requirements (CIOMS, FDA, EMA).
• Experience with pharmacovigilance databases and safety reporting systems.

Responsibilities

• Receive, process and evaluate adverse event reports from healthcare professionals, consumers and trials.
• Ensure timely and accurate safety reporting to regulatory authorities worldwide.
• Conduct literature reviews for safety signals and support signal detection activities.
• Develop and update safety documents such as Investigator Brochures and Risk Management Plans.
• Collaborate with Regulatory Affairs, Medical Affairs and Clinical Development on safety matters.

Skills

Pharmacovigilance

Adverse event reporting

Regulatory compliance

Data analysis

Education

Degree in Pharmacy

Degree in Nursing

Degree in Life Sciences

Tools

PV databases

Safety reporting systems

Job description

About the Role

Our client, a key player in the pharmaceutical industry , is actively seeking a dedicated Pharmacovigilance Specialist to join their team in Durban . This role is crucial for ensuring the safety of pharmaceutical products by monitoring, detecting, and reporting adverse events. You will play a vital role in maintaining regulatory compliance and contributing to the overall safety profile of our client's medicines. This is an excellent opportunity for individuals passionate about patient safety and regulatory affairs within the dynamic pharmaceutical landscape.

Key Responsibilities

• Receive, process, and evaluate adverse event reports from various sources (healthcare professionals, consumers, clinical trials).
• Ensure timely and accurate reporting of safety information to regulatory authorities worldwide according to global regulations.
• Conduct literature reviews for potential safety signals and contribute to signal detection activities.
• Participate in the development and updating of safety-related documents, such as Investigator Brochures and Risk Management Plans.
• Collaborate with internal departments (e.g., Regulatory Affairs, Medical Affairs, Clinical Development) on safety matters.

Requirements

• Degree in Pharmacy, Nursing, Life Sciences, or a related field.
• Minimum of 3 years of experience in pharmacovigilance or drug safety within the pharmaceutical sector.
• Thorough understanding of global drug safety regulations and reporting requirements (e.g., CIOMS, FDA, EMA).
• Experience with pharmacovigilance databases and safety reporting systems.
• Strong analytical skills and attention to detail for accurate data assessment and reporting.

Benefits

• Competitive salary commensurate with experience.
• Flexible remote work arrangements available.
• Comprehensive health and wellness benefits.
• Opportunities for professional growth and specialized training in drug safety.
• A commitment to fostering a culture of safety and continuous improvement.