Associate Medical Safety Director (Sponsor-Dedicated)

Addiction Foods Nz Ltd.

Cape Town

On-site

ZAR 1,200,000 - 1,800,000

Full time

14 days+

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Job summary

IQVIA is a leading global provider of clinical research services, insights and healthcare intelligence. The Associate Medical Safety Director- Sponsor Dedicated will contribute to pharmacovigilance operations, provide medical safety expertise, and support safety governance across post-marketing and development activities.

The role requires medical training and clinical/pharmaceutical experience with strong analytical and communication skills.

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 industry or equivalent.
Knowledge of regulations for clinical research including safety and GCP.
Maintain knowledge of assigned product portfolio and literature.
Experience in signal detection, aggregate reports and risk management.
Ability to synthesize and analyze data and communicate complex issues.

Responsibilities

Provide aggregate safety reviews to oversight product safety profile.
Lead signal detection and analysis including reports and data sources.
Contribute to regulatory safety documents (IND/EU/US safety reports).
Contribute to Development Risk Management Plans and EU/US risk management.
Review and contribute to benefit-risk evaluation of drugs in trials and post-marketing.
Provide safety oversight for label development and updates.
Contribute to Integrated Safety Summary or Common Technical Document.
Communicate safety findings in internal and external meetings.