Pharmacovigilance Professional

4 days ago


Johannesburg, Gauteng, South Africa LexisNexis South Africa Shared Services (Pty) Ltd Company Full time

A career at LexisNexis South Africa Shared Services (Pty) Ltd Company offers opportunities for growth and development in the exciting field of clinical research. Our Clinical Trials team is dedicated to delivering high-quality results, and we are seeking a talented Senior Administrator to join our team.

The ideal candidate will possess a strong background in pharmacovigilance, with expertise in adverse event reporting and data analysis.

Key Accountabilities
  • Guide adverse event coding, retrieval, and analysis activities in drug safety and clinical trials.
  • Prepare reports for submission to domestic and international regulatory agencies.
  • Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations.

The successful candidate will also be responsible for guiding reviews of safety sections of NDA submissions.

Qualifications and Experience
  • Medical degree (MD or equivalent), or PharmD.
  • Experience with protocol amendments and ICF updates beneficial.
  • 2 years' experience in technical or medical writing preferred.


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