Associate Medical Safety Director x1
Job Details
- Job Title: Associate Medical Safety Director – Sponsor Dedicated
- Company: IQVIA
- Location: Bloemfontein (Home-based)
- Job Type: Full-time
- Work Setup: Remote / Home-based
- Salary: R1,533,906 per annum
Job Overview
This is a senior-level medical and pharmacovigilance role focused on ensuring the safety of pharmaceutical products throughout their lifecycle.
You will be responsible for evaluating drug safety data, identifying risks, and supporting regulatory compliance. The role involves working closely with clinical, regulatory, and research teams to ensure that medicines are safe for patients both during clinical trials and after they reach the market.
Job Description
The Associate Medical Safety Director plays a key role in medical safety oversight, including adverse event evaluation, signal detection, and benefit-risk assessment of drugs.
You will contribute to safety reports, regulatory submissions, and clinical documentation while acting as a medical expert within pharmacovigilance operations. The role also includes collaboration with internal and external stakeholders, including health authorities.
Key Responsibilities
Medical Safety & Risk Management
- Provide pharmacovigilance (PV) expertise across product portfolios
- Conduct medical evaluations of adverse drug reactions (ADRs)
- Perform benefit-risk assessments for clinical and post-marketing drugs
- Contribute to risk management plans and safety strategies
Signal Detection & Data Analysis
- Lead signal detection and analysis processes
- Review safety data and identify potential risks
- Present findings and contribute to safety decision-making
Regulatory & Reporting
- Contribute to:
- Periodic Safety Update Reports (PSURs)
- Benefit-Risk Evaluation Reports (PBRERs)
- Development Safety Update Reports (DSURs)
- Assist in responses to health authority queries
- Support regulatory submissions and documentation
Clinical & Trial Support
- Review clinical trial safety data
- Contribute to study protocols and investigator brochures
- Provide input into labeling and safety documentation
Collaboration & Leadership
- Act as a medical consultant to internal teams
- Participate in safety governance meetings
- Communicate complex medical data clearly to stakeholders
Requirements
Qualifications:
- Medical Degree (MBChB or equivalent) from a recognized institution
Experience:
- Around:
- 3 years clinical practice experience
- +2 years in pharmaceutical or related industry
(or equivalent combination)
Technical Knowledge:
- Pharmacovigilance and drug safety regulations
- Clinical research and Good Clinical Practice (GCP)
- Signal detection and risk management processes
- Knowledge of regulatory reporting requirements
Skills:
- Strong analytical and critical thinking ability
- Ability to interpret complex clinical data
- Excellent written and verbal communication
- Ability to manage multiple priorities and deadlines
- Strong collaboration and stakeholder management skills
Key Competencies
- High-level medical expertise
- Attention to detail and accuracy
- Problem-solving and decision-making
- Ability to work under pressure
- Adaptability and flexibility
- Professional integrity and ethical standards
Important Notes
- This is a highly specialized and senior role
- Requires both clinical and pharmaceutical industry experience
- IQVIA maintains a strict zero-tolerance policy on recruitment fraud