Pharmacovigilance Scientist

Placements24; Mossel Bay; On-site; ZAR 700,000 - 1,000,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Pension plan

Paid time off

Professional development

Job summary

Placements24 is seeking a Pharmacovigilance Scientist to manage safety data, assess adverse events, and ensure regulatory compliance from Mossel Bay, Western Cape. The role emphasizes collaboration across departments and external partners to protect patient safety.

The candidate will contribute to PSURs and RMPs, oversee case processing, and uphold GVP guidelines while maintaining high data quality and timely reporting. This position offers a stable, impactful career in pharma safety.

Qualifications

• Bachelor’s degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field; a Master’s degree is preferred.
• 3–5 years of experience in pharmacovigilance or drug safety.
• Solid understanding of pharmacovigilance principles, regulatory requirements (ICH E2B/E2C) and GVP guidelines.
• Experience with safety databases and adverse event reporting systems; MedDRA/WHODrug familiarity.

Responsibilities

• Collect, review, and process adverse event reports from various sources.
• Assess seriousness, causality and expectedness of reported AEs per guidelines and policies.
• Enter AE data into the pharmacovigilance database accurately and timely.
• Assist in preparation of PSURs, RMPs and other safety-related regulatory documents.
• Monitor and analyze safety data trends for signals.
• Collaborate with Medical Affairs, Clinical Operations, Regulatory Affairs and external partners on safety matters.
• Ensure compliance with global pharmacovigilance regulations and SOPs.
• Participate in safety surveillance and risk-benefit assessments.
• Respond to safety queries from regulatory authorities and stakeholders.
• Contribute to development and maintenance of pharmacovigilance procedures.

Skills

Pharmacovigilance

Safety data analysis

AE reporting

Medical terminology

Case processing

Data entry

Education

Bachelor’s degree in Pharmacy or related healthcare field

Master’s degree preferred

Tools

Safety databases

AE reporting systems

MedDRA/WHODrug knowledge

Job description

About the Role

Our client, a globally recognized pharmaceutical company committed to patient safety, is actively seeking a skilled Pharmacovigilance Scientist. This critical role involves the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The Scientist will be responsible for managing and evaluating safety data, ensuring compliance with global safety regulations, and contributing to the overall safety profile of our medicinal products. This is an excellent career opportunity for a dedicated professional to make a tangible impact on public health from our base in Mossel Bay, Western Cape . We are passionate about ensuring the safety and efficacy of our treatments for all patients.

Key Responsibilities

• Collect, review, and process adverse event (AE) reports from various sources (e.g., healthcare professionals, patients, literature).
• Assess seriousness, causality, and expectedness of reported AEs according to regulatory guidelines and company policies.
• Enter AE data into the pharmacovigilance database accurately and in a timely manner.
• Contribute to the preparation of periodic safety update reports (PSURs), risk management plans (RMPs), and other safety-related regulatory documents.
• Monitor and analyze safety data trends for potential signals.
• Collaborate with internal departments (e.g., Medical Affairs, Clinical Operations, Regulatory Affairs) and external partners on safety-related matters.
• Ensure compliance with global pharmacovigilance regulations and company SOPs.
• Participate in safety surveillance activities and risk-benefit assessments.
• Respond to safety queries from regulatory authorities and other stakeholders.
• Contribute to the development and maintenance of pharmacovigilance procedures.

Requirements

• Bachelor's degree in Pharmacy, Nursing, Medicine, Life Sciences, or a related healthcare field. A Master's degree or equivalent experience is preferred.
• Minimum of 3-5 years of experience in pharmacovigilance or drug safety.
• Thorough understanding of pharmacovigilance principles, regulatory requirements (e.g., ICH E2B, E2C), and GVP guidelines.
• Experience with safety databases and adverse event reporting systems.
• Strong analytical skills with the ability to assess medical information and safety data.
• Excellent written and verbal communication skills, with a high degree of accuracy.
• Ability to work independently and manage multiple tasks under pressure.
• Proficiency in data entry and case processing.
• Familiarity with medical terminology and coding conventions (e.g., MedDRA, WHODrug).
• Commitment to patient safety and ethical conduct.

Benefits

• Our client offers a competitive salary, comprehensive medical, dental, and vision insurance, a robust retirement plan, generous paid time off, and opportunities for continuous professional development. The role is situated in the scenic coastal town of Mossel Bay, Western Cape , providing a unique lifestyle balance. Join our dedicated team and contribute to ensuring the safety of medicines for patients worldwide.