Pharmacovigilance Specialist

Placements24; Mossel Bay; Hybrid; ZAR 420,000 - 570,000; Full time

Benefits offered by this job

Competitive bonus potential

Health and retirement benefits

Paid time off

Job summary

Placements24 is seeking a Pharmacovigilance Specialist for a hybrid role in Mossel Bay. You will collect and assess adverse event data, ensure timely reporting to authorities, and maintain PV databases while collaborating with Regulatory Affairs and Clinical Operations.

The role requires a relevant healthcare degree and 2–3 years of PV experience, with strong analytical and communication skills. Training in drug safety and regulatory compliance is available.

Qualifications

• Degree in Pharmacy, Nursing, Life Sciences, or related healthcare field.
• 2-3 years of Pharmacovigilance or drug safety experience.
• Familiarity with CIOMS/ICH safety reporting guidelines.
• Experience with safety databases (Argus, ARISg) is a plus.
• Strong analytical skills and meticulous attention to detail.
• Excellent written and verbal communication abilities.

Responsibilities

• Collect, process, and assess adverse event reports from various sources.
• Ensure timely and accurate reporting of safety data to regulatory authorities worldwide.
• Maintain the pharmacovigilance database and ensure data quality and integrity.
• Collaborate with Regulatory Affairs, Clinical Operations and external partners on safety matters.
• Contribute to preparation of PSURs and risk management plans (RMPs).
• Stay updated on pharmacovigilance regulations and guidelines globally.

Skills

Analytical skills

Attention to detail

Written communication

Verbal communication

Team collaboration

Education

Degree in Pharmacy, Nursing, Life Sciences, or related healthcare field

Tools

Argus

ARISg

Job description

About the Role

Our client is seeking a vigilant and precise Pharmacovigilance Specialist to join their team in Mossel Bay . This hybrid role is crucial for safeguarding public health by ensuring the safety of our pharmaceutical products post-marketing. You will be responsible for the collection, assessment, and reporting of adverse event data, maintaining compliance with global regulatory requirements. This position offers the chance to contribute to patient safety initiatives while working within a supportive team environment that values accuracy and diligence in managing drug safety information, balancing remote tasks with necessary on-site responsibilities.

Key Responsibilities

• Collect, process, and assess adverse event reports from various sources, including healthcare professionals, patients, and literature.
• Ensure timely and accurate reporting of safety data to regulatory authorities worldwide.
• Maintain the pharmacovigilance database and ensure data quality and integrity.
• Collaborate with internal departments (e.g., Regulatory Affairs, Clinical Operations) and external partners on safety matters.
• Contribute to the preparation of periodic safety update reports (PSURs) and risk management plans (RMPs).
• Stay updated on pharmacovigilance regulations and guidelines globally.

Requirements

• Degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field.
• 2-3 years of experience in Pharmacovigilance or drug safety.
• Familiarity with global safety reporting requirements and guidelines (e.g., CIOMS, ICH).
• Experience with safety databases (e.g., Argus, ARISg) is a plus.
• Strong analytical skills and meticulous attention to detail.
• Excellent written and verbal communication abilities.

Benefits

• Competitive annual salary and potential for performance-related bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan.
• Paid time off and sick leave.
• Opportunities for specialized training in drug safety and regulatory compliance.