Pharmacovigilance Specialist - Drug Safety

Placements24; Sandton; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Hybrid work model

Medical benefits

Job summary

Placements24 is seeking a Pharmacovigilance Specialist in Sandton, Gauteng to join the drug safety team. You will collect, process, and report adverse event information and contribute to safety surveillance activities in a hybrid role.

The ideal candidate has a Bachelor's degree in a healthcare field and at least 2 years of pharmacovigilance experience, with familiarity in global safety regulations and safety databases. Strong data handling, communication, and teamwork skills are essential.

Qualifications

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• 2+ years of experience in pharmacovigilance or drug safety.
• Familiarity with global safety reporting regulations (e.g., FDA, EMA, CIOMS).
• Experience with safety databases (e.g., Argus, ArisG) is highly desirable.
• Strong understanding of medical terminology and case processing.

Responsibilities

• Collect, process, and report adverse event (AE) and product complaint information according to regulatory requirements and company procedures.
• Ensure timely and accurate data entry into the safety database.
• Perform case narrative writing and medical coding of adverse events.
• Contribute to the preparation of PSURs and other safety reporting documents.
• Monitor literature for relevant safety information and emerging risks.
• Support regulatory inspections and audits related to pharmacovigilance.
• Collaborate with internal departments and external stakeholders on safety matters.
• Maintain up-to-date knowledge of global pharmacovigilance regulations and guidelines.
• Participate in safety risk management activities and strategy development.

Skills

Pharmacovigilance

Medical terminology

Data entry

Communication

Teamwork

Education

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

Tools

Argus

ArisG

Microsoft Office

Job description

About the Role

Our client, a prominent pharmaceutical company, is seeking a dedicated Pharmacovigilance Specialist to join their drug safety team in Sandton, Gauteng . This role is crucial for monitoring the safety of our marketed pharmaceutical products and investigational drugs, ensuring patient well-being and regulatory compliance. You will be responsible for collecting, processing, and reporting adverse event data, as well as contributing to safety surveillance activities. This is an excellent opportunity for an individual with a keen interest in drug safety and regulatory affairs to contribute to a leading healthcare organization. We are committed to maintaining the highest standards of safety and efficacy. The ideal candidate will have a strong understanding of pharmacovigilance principles and a meticulous approach to data handling.

Key Responsibilities

• Collect, process, and report adverse event (AE) and product complaint information according to regulatory requirements and company procedures.
• Ensure timely and accurate data entry into the safety database.
• Perform case narrative writing and medical coding of adverse events.
• Contribute to the preparation of Periodic Safety Update Reports (PSURs) and other safety reporting documents.
• Monitor literature for relevant safety information and emerging risks.
• Support regulatory inspections and audits related to pharmacovigilance.
• Collaborate with internal departments (e.g., Medical, Regulatory, Clinical) and external stakeholders on safety matters.
• Maintain an up-to-date knowledge of global pharmacovigilance regulations and guidelines.
• Participate in safety risk management activities and strategy development.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• Minimum of 2 years of experience in pharmacovigilance or drug safety.
• Familiarity with global safety reporting regulations (e.g., FDA, EMA, CIOMS).
• Experience with safety databases (e.g., Argus, ArisG) is highly desirable.
• Strong understanding of medical terminology and case processing.
• Excellent attention to detail, organizational, and time management skills.
• Good written and verbal communication abilities.
• Ability to work effectively in a team and independently.
• Proficiency in Microsoft Office Suite.

Benefits

Our client offers a competitive salary, comprehensive medical and retirement benefits, and opportunities for professional development in the field of drug safety. This hybrid role offers flexibility in Sandton . Join a company that prioritizes employee well-being and career growth, fostering a collaborative and supportive work environment. Access to continuous training and industry conferences is provided.