Senior Pharmacovigilance Officer - Global Drug Safety

Placements24

Upington

On-site

ZAR 900,000 - 1,300,000

Full time

33 hours ago
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Benefits offered by this job

Medical coverage
Dental coverage
Retirement plan
Career growth

Job summary

Placements24 is seeking a Senior Pharmacovigilance Officer for an on-site role in Upington, Northern Cape. The candidate will manage adverse event reports, ensure regulatory compliance, and contribute to ongoing product safety assessments.

The role requires a Bachelor’s degree in a healthcare field and at least four years in pharmacovigilance, with strong data management and analytical skills. On-site work with opportunities for professional growth and safety system improvements.

Qualifications

  • Bachelor's degree in Pharmacy, Nursing, Life Sciences, or related healthcare field.
  • Minimum of 4 years of experience in pharmacovigilance or drug safety.
  • Thorough understanding of global pharmacovigilance regulations (e.g., ICH E2B, E2C) and reporting requirements.
  • Proficiency in using safety databases and data management systems.
  • Strong medical terminology knowledge and ability to assess adverse event seriousness and causality.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Meticulous attention to detail and strong organizational abilities.
  • Effective written and verbal communication skills.
  • Ability to work independently and collaboratively in a team environment.

Responsibilities

  • Receive, process, and evaluate adverse event reports from various sources (healthcare professionals, patients, literature).
  • Ensure timely and accurate reporting of adverse events to regulatory authorities worldwide per deadlines.
  • Conduct detailed case assessments including causality and seriousness determinations.
  • Maintain the global safety database ensuring data integrity.
  • Assist in PSURs and regulatory safety documents.
  • Monitor safety signals and participate in signal detection activities.
  • Collaborate with Clinical Operations, Medical Affairs, Regulatory Affairs on safety matters.
  • Assist in development and implementation of pharmacovigilance procedures and SOPs.
  • Support regulatory inspections and internal audits related to pharmacovigilance.
  • Stay current with evolving pharmacovigilance regulations and guidelines.
  • Provide training to junior staff on pharmacovigilance processes.
  • Contribute to risk management plans and benefit-risk assessments.

Skills

Analytical skills
Attention to detail
Team collaboration
Independent work

Education

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

Tools

Safety databases
Data management systems

Job description

Placements24 is seeking a Senior Pharmacovigilance Officer for an on-site role in Upington, Northern Cape. The candidate will manage adverse event reports, ensure regulatory compliance, and contribute to ongoing product safety assessments.

The role requires a Bachelor’s degree in a healthcare field and at least four years in pharmacovigilance, with strong data management and analytical skills. On-site work with opportunities for professional growth and safety system improvements.

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