Pharmacovigilance Intern: Medical Safety & Risk

Career27

Cape Town

On-site

ZAR 1,000,000 - 1,600,000

Full time

4 days ago
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Job summary

IQVIA is seeking an Associate Medical Safety Director for sponsor-dedicated work across multiple regions including South Africa. The role covers medical safety oversight, signal detection, risk management, and preparation of safety reports for regulatory bodies.

Ideal candidates hold a medical degree with clinical and pharmaceutical industry experience. The position requires strong analytical, communication, and cross-functional collaboration skills, and offers engagement with global

Qualifications

  • Medical degree from an accredited and internationally recognized medical school.
  • Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience.
  • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including safety and good clinical practice.
  • Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature.
  • Experience in Signal detection, Aggregate reports and Risk management.

Responsibilities

  • Providing aggregate reviews of safety information to maintain oversight of a product's safety profile.
  • Leads signal detection and analysis, including strategy, frequency, and timing; reviews Signal Detection Reports and data; raises potential signals.
  • Medical review and contribution to various EU and US safety reports (e.g., IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU PSURs).
  • Contribute to Development Risk Management Plans and Risk Management Plans for EU/US.
  • Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up.
  • Provide safety oversight for label development and updates.
  • Contribute to Integrated Safety Summary or Common Technical Document.
  • Review Adverse Events and post-marketing ADRs; collaborate with pharmacovigilance teams.
  • Represent safety findings in internal/external meetings and provide safety support at Governance meetings.

Skills

Medical degree
Clinical practice
Pharmacovigilance
Signal detection
Regulatory knowledge
Data synthesis
Communication

Education

Medical degree
Clinical/pharma experience

Job description

IQVIA is seeking an Associate Medical Safety Director for sponsor-dedicated work across multiple regions including South Africa. The role covers medical safety oversight, signal detection, risk management, and preparation of safety reports for regulatory bodies.

Ideal candidates hold a medical degree with clinical and pharmaceutical industry experience. The position requires strong analytical, communication, and cross-functional collaboration skills, and offers engagement with global

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