Associate Medical Safety Director - Global Pharmacovigilance

Law Security & Investigations; Gauteng; On-site; ZAR 1,200,000 - 2,100,000; Full time

Job summary

IQVIA is seeking an Associate Medical Safety Director to join the Sponsor Dedicated Lifesciences Safety team. The role covers aggregate safety reviews, signal detection, and medical evaluation across post‑marketing and development safety activities for multiple portfolios.

You will contribute to safety governance, regulatory reporting, and risk management while maintaining up‑to‑date knowledge of pharmacovigilance guidelines and best practices; travel to several listed locations may be required.

Qualifications

• A 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 GCP safety.
• Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature.
• Experience in Signal detection, Aggregate reports and Risk management.
• Ability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues.
• Ability to establish and meet priorities, deadlines, and objectives.

Responsibilities

• Providing aggregate reviews of safety information to maintain oversight of a product's safety profile.
• Leads signal detection and analysis, review signal detection reports, raises potential signals.
• Providing medical review for various regulatory reports (IND, EU PSURs, US risk reports).
• Providing medical review for Development Risk Management Plans and Risk Management Plans.
• Reviewing benefit-risk evaluation of drugs in trials and post marketing setup.
• Providing safety oversight for label development, reviews and updates.
• Provide medical safety contributions to the Integrated Safety Summary/CTD.
• Performing medical review of trial-related AEs and ADRs and act as consultant to PV teams.
• Representing safety findings at internal/external meetings.
• Providing medical safety support to Safety Governance meetings.

Skills

Medical degree

Clinical practice experience

Regulatory knowledge (GCP, safety regs

Data synthesis & analysis

Communication (oral & written)

Project management / multitasking

Education

MD/MBBS from accredited medical school

Job description

IQVIA is seeking an Associate Medical Safety Director to join the Sponsor Dedicated Lifesciences Safety team. The role covers aggregate safety reviews, signal detection, and medical evaluation across post‑marketing and development safety activities for multiple portfolios.

You will contribute to safety governance, regulatory reporting, and risk management while maintaining up‑to‑date knowledge of pharmacovigilance guidelines and best practices; travel to several listed locations may be required.