Remote Medical Safety Director

IQVIA Inc; Centurion; On-site; ZAR 1,200,000 - 1,800,000; Full time

Job summary

IQVIA Lifecyle Safety Medical seeks an Associate Medical Safety Director to oversee safety data reviews, contribute to signal detection, and provide medical evaluation for post-marketing ADRs and regulatory submissions. You will participate in risk management planning and safety governance, ensuring robust safety signal handling and accurate reporting across products.

You will collaborate with pharmacovigilance case processing teams and external stakeholders, maintaining up-to-date knowledge of

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.
• 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 and therapeutic area.
• 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.
• Providing medical review for regulatory reports (IND Annual Reports, EU PSURs, US PBRERs).
• Contributing to Development Risk Management Plans and EU/US risk management strategies.
• Reviewing benefit-risk evaluations of drugs in clinical trials and post-marketing setups.
• Providing safety oversight for label development and updates.
• Contributing to Integrated Safety Summary or Common Technical Document.

Skills

Medical knowledge

Regulatory knowledge

Signal detection

Data synthesis

Communication skills

Education

Medical degree

Tools

Pharmacovigilance tools

Job description

IQVIA Lifecyle Safety Medical seeks an Associate Medical Safety Director to oversee safety data reviews, contribute to signal detection, and provide medical evaluation for post-marketing ADRs and regulatory submissions. You will participate in risk management planning and safety governance, ensuring robust safety signal handling and accurate reporting across products.

You will collaborate with pharmacovigilance case processing teams and external stakeholders, maintaining up-to-date knowledge of